Data / Medical devices / United States / Covidien LLC
Covidien LLC: FDA-registered device maker in Mansfield, MA, United States, 45 510(k) clearances
Covidien LLC is registered with the FDA (registration 1282497) in Mansfield, MA, United States. It lists 19 device types. The FDA files 45 510(k) clearances under its listings, the newest dated January 14, 2022. 54 recall events name it as the recalling firm (6 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1282497
- Address
- 15 Hampshire Street, Mansfield, MA, United States, 02048
- Owner or operator
- Covidien llc (1282497)
- Roles
- Specification developer
- First device listed
- December 23, 2002
- Registered through
- 2027
- Brand names listed
- Acute and Chronic Catheter Repair Kit, Argyle, Argyle Acute Single Lumen Catheters and Kits, Argyle Adult Peritoneal Dialysis Accessory, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender, Argyle Dialysis Catheter Accessories, Argyle Faller Tunneling Trocar, Argyle J/Straight Stainless Steel Guidewire and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 14, 2022 | K213602 | Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit | FJS | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| January 17, 2020 | K192302 | Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter | MPB | Unknown | Covidien, LLC | accessdata.fda.gov |
| July 27, 2018 | K180485 | Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender | FJS | Unknown | Covidien, LLC | accessdata.fda.gov |
| March 30, 2017 | K170635 | Chameleon PTA Balloon Catheter | LIT | Substantially Equivalent | Av Medical Technologies, Ltd. | accessdata.fda.gov |
| January 17, 2017 | K163231 | Chameleon PTA Balloon Catheter | LIT | Substantially Equivalent | Av Medical Technologies, Ltd. | accessdata.fda.gov |
| January 31, 2013 | K123196 | PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISION SI CHRONIC CATHETER, PALINDROME PRECISION HSI CHRONIC CATH | MSD | Substantially Equivalent | Covidien | accessdata.fda.gov |
| September 21, 2012 | K121848 | SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CM | MSD | Unknown | Medical Components, Inc. | accessdata.fda.gov |
| April 4, 2012 | K120674 | MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER | MPB | Unknown | Covidien | accessdata.fda.gov |
| September 28, 2011 | K112477 | PALINDROME H, SI, HSI CHRONIC CATHETER | NYU | Unknown | Covidien | accessdata.fda.gov |
| August 30, 2011 | K111817 | PALINDROME RT CHRONIC CATHETER | MSD | Unknown | Covidien | accessdata.fda.gov |
| August 4, 2011 | K111372 | TAL PALLINDROME (TM) SYMMETRIC TIP DUAL LUMEN CATHETER, MAHURKAR (R) MAXID (TM) DUAL LUMEN CATHETER, PALINDROME (TM)... | MSD | Unknown | Covidien | accessdata.fda.gov |
| December 22, 2010 | K102605 | MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER | NIE | Unknown | Covidien, LLC, Formerly Registered AS Tyco Healthca | accessdata.fda.gov |
| November 19, 2009 | K092797 | ACUTE AND CHRONIC CATHETER REPAIR KIT | NFK | Unknown | Kendall | accessdata.fda.gov |
| October 30, 2009 | K092205 | PALINDROME P HEMODIALYSIS CATHETER | MSD | Unknown | Covidien Lp, Formerly Registered AS Kendall | accessdata.fda.gov |
| May 19, 2004 | K041006 | TANDEM-CATH HEMODIALYSIS CATHETER, MODEL 10 FR | MSD | Substantially Equivalent | Kendall | accessdata.fda.gov |
| May 13, 2003 | K030209 | MAHURKAR OPLUS CATHETER, MODEL 13.5 FR | MPB | Substantially Equivalent | The Kendall Company | accessdata.fda.gov |
| April 10, 2002 | K020089 | MAHURKAR TRIPLE LUMEN CATHETER, 12 FR | NIE | Substantially Equivalent | The Kendall Company | accessdata.fda.gov |
| April 9, 2001 | K002902 | TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS | MSD | Substantially Equivalent | The Kendall Company | accessdata.fda.gov |
| November 25, 1998 | K981365 | MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONS | MSD | Substantially Equivalent | Sherwood Medical Co. | accessdata.fda.gov |
| December 15, 1995 | K950042 | SWAN NECK PRESTERNAL PERITONEAL DIALYSIS CATHETER | FJS | Substantially Equivalent | Accurate Surgical Instruments Co. | accessdata.fda.gov |
| March 22, 1995 | K943349 | MAHURKAR DUAL LUMEN CATHETER | FOZ | Unknown | Quinton, Inc. | accessdata.fda.gov |
| May 4, 1992 | K920515 | INSERTION | FJS | Substantially Equivalent | Accurate Surgical Instruments Co. | accessdata.fda.gov |
| September 19, 1991 | K910786 | TROCAR (FALLER STYLET) | FJS | Substantially Equivalent | Accurate Surgical Instruments Co. | accessdata.fda.gov |
| August 22, 1991 | K910785 | TITANIUM CATHETER EXTENDER | FJS | Substantially Equivalent | Accurate Surgical Instruments Co. | accessdata.fda.gov |
| August 15, 1991 | K910787 | TITANIUM CONNECTOR (2 PART) | FKO | Substantially Equivalent | Accurate Surgical Instruments Co. | accessdata.fda.gov |
| January 29, 1990 | K896252 | MODIFIED QUINTON SINGLE LUMEN CATHETER | MPB | Substantially Equivalent | Quinton, Inc. | accessdata.fda.gov |
| March 27, 1989 | K890288 | PERITONEAL CATHETERS WITH AN ADDED FUNCTION | FJS | Substantially Equivalent | Quinton, Inc. | accessdata.fda.gov |
| July 28, 1988 | K882097 | TUNNELING STYLET | DRB | Substantially Equivalent | Quinton, Inc. | accessdata.fda.gov |
| February 17, 1988 | K874633 | PERMCATH INSERTION TRAY | LFJ | Unknown | Quinton, Inc. | accessdata.fda.gov |
| October 7, 1987 | K873727 | PULL-APART INTRODUCER (SHEATH) | DYB | Substantially Equivalent | Quinton, Inc. | accessdata.fda.gov |
| September 30, 1987 | K873394 | OVAL PULL-APART SHEATH/DILATOR | DYB | Substantially Equivalent | Quinton, Inc. | accessdata.fda.gov |
| June 17, 1987 | K871942 | PERM-CATH CATHETER KIT | LFJ | Substantially Equivalent | Quinton, Inc. | accessdata.fda.gov |
| June 17, 1987 | K871749 | ADULT PERM-CATH 40CM. | LFJ | Substantially Equivalent | Quinton, Inc. | accessdata.fda.gov |
| May 18, 1987 | K871730 | MODIFIED USE OF PULL-APART INTRODUCER SET | FKO | Substantially Equivalent | Quinton, Inc. | accessdata.fda.gov |
| August 19, 1986 | K862288 | MODIFICATION OF TISSUE DILATOR | DRE | Substantially Equivalent | Quinton, Inc. | accessdata.fda.gov |
| June 19, 1986 | K862046 | SWAN-NECK PERITONEAL DIALYSIS CATHETERS | FJS | Substantially Equivalent | Accurate Surgical Instruments Co. | accessdata.fda.gov |
| July 26, 1985 | K850214 | STERILE CATHETERS-CATHETER PERITONEAL LONG-TERM IN | FJS | Substantially Equivalent | Accurate Surgical Instruments Co. | accessdata.fda.gov |
| May 17, 1985 | K844193 | QUINTON INJECTION SEALING CAP | FOZ | Substantially Equivalent | Quinton, Inc. | accessdata.fda.gov |
| January 18, 1985 | K844692 | PEDIATRIC SIZED HEMOCATH CATHETER | FIQ | Substantially Equivalent | Quinton, Inc. | accessdata.fda.gov |
| November 8, 1984 | K840815 | LUER LOCKING ADAPTER(MATERIAL CHANGE) | FOZ | Substantially Equivalent | Quinton, Inc. | accessdata.fda.gov |
| April 20, 1984 | K840415 | HEMOCATH | FIQ | Substantially Equivalent | Quinton, Inc. | accessdata.fda.gov |
| March 5, 1984 | K840424 | HEMOCATH REPAIR KIT | KNZ | Substantially Equivalent | Quinton, Inc. | accessdata.fda.gov |
| December 31, 1981 | K813488 | CATHETER REGULAR | FJS | Substantially Equivalent | Accurate Surgical Instruments Co. | accessdata.fda.gov |
| May 16, 1978 | K780449 | BETA CAP SYSTEM | FJS | Substantially Equivalent | Quinton, Inc. | accessdata.fda.gov |
| June 14, 1977 | K770977 | CARDIOVASCULAR SPRING GUIDES | DQX | Substantially Equivalent | Lake Region Mfg., Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 19, 2024 | 95447 | Class II | Ongoing | Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm x 75cm (CFN CH06-40-75US), 7mm x 40mm x 75cm (CFN CH07-40-75US), 8mm x 40mm x 75cm (CFN CH08-40-75US), 9mm x 40mm x 75cm | Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing. | accessdata.fda.gov |
| March 15, 2024 | 94266 | Class II | Ongoing | Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 19 cm (Symmetrical Tip, Heparin Coating, Silver Ion Sleeve and Tal VenaTrac Stylet- Intended for acute and chronic hemodialysis, apheresis, and in | Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit due to the absence of the heparin coating | accessdata.fda.gov |
| December 21, 2023 | 93768 | Class II | Ongoing | Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT 88861919-71 SURGILON* 1 BLK 7X75CM PCT | Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound dehiscence and hemorrhage/blood loss/ bleeding at a critical level. | accessdata.fda.gov |
| August 22, 2023 | 92902 | Class II | Ongoing | Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm | Some catheter kits labeled as 23 cm implant length incorrectly included catheters of 28 cm implant length; the actual catheter implant length is identifiable based upon the correct labeling on the catheter body. | accessdata.fda.gov |
| June 28, 2023 | 92660 | Class I | Ongoing | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, IC Tray REF:8888101001HP | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial ob | accessdata.fda.gov |
| March 22, 2023 | 92004 | Class II | Ongoing | VersaOne Reusable Positioning Cannula 8 mm Standard, Model Number RC8STS | There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaOneTM Reusable Positioning Cannula, located where the Cannula and Body components are welded together. | accessdata.fda.gov |
| December 7, 2022 | 91206 | Class I | Ongoing | MAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter, Sterile, Single Use, Rx Only: 13.5cm, Straight Extensions, Kit - Model No. 8888135131; 13.5 cm, Curved Extensions, Kit - Model No. 8888135132; 13.5cm, Pre-Cur | There is a potential leaking condition within the hub of affected devices, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use. | accessdata.fda.gov |
| June 8, 2022 | 90311 | Class I | Ongoing | Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion. | There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use. | accessdata.fda.gov |
| June 7, 2022 | 90519 | Class II | Ongoing | TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal. Model Number: 7209808 | Electrical component failure within the control unit. The observed failure mode is a loss of function of the device when used with handpiece and foot switch. | accessdata.fda.gov |
| December 17, 2021 | 89418 | Class II | Ongoing | Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm x 40 mm; Cardiovascular. Product Numbers CH08-40-75GB and CH08-40-75US | The firm has received six (6) complaint reports from customers indicating difficulty removing the balloon protector sleeve from the catheter (e.g., excessive force required to remove the protector sleeve). If the balloon is damaged while removing the protector sleeve and the catheter is subsequently used in a patient procedure, patient harm may potentially o | accessdata.fda.gov |
| December 6, 2021 | 89182 | Class II | Terminated | LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837 | Customers reported that the device jaws were difficult to open or would not open following application on tissue. Use of a device with this potential assembly issue could result in the potential for bleeding, unintended tissue injury or loss, and delay in treatment while an alternate device is obtained. | accessdata.fda.gov |
| November 12, 2021 | 89024 | Class II | Ongoing | Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information on the battery charging progress and battery pack status Item Code: CBCA | Intermittent risk of electric shock to users if an affected charger is used in conjunction with a faulty or bypassed institutions Mains Protective Earth (Ground) circuit | accessdata.fda.gov |
| November 4, 2021 | 88987 | Class I | Terminated | Puritan Bennett 980 Series Ventilator, 980A1ENNISB | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. | accessdata.fda.gov |
| September 29, 2021 | 88817 | Class II | Terminated | Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1 | The firm identified an error in the device temperature monitoring circuitry which is designed to interrupt energy delivery in the event of a primary cooling system failure. Use of an affected device in conjunction with a primary cooling system failure could lead to the applicator tip overheating and associated heat damage which could result in an allergic/to | accessdata.fda.gov |
| June 23, 2021 | 88271 | Class II | Terminated | Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic energy to drive the active blade. Product Number: SCGAA | Potential for a manufacturing assembly error-may result in a non-functional audio indicator of device activation or a non-functional device, may cause unintended thermal burn, hemorrhage, or tissue damage and a delay of treatment while an alternate device is located | accessdata.fda.gov |
| March 23, 2021 | 87618 | Class II | Terminated | Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For use with Signia stapling system. Staple line reinforcement has applications in abdominal, gynecologic, pediatric and thoracic surgery for resec | Potential for the pouch to contain an extra laminate layer, creating the potential for the device sterility to be compromised. The inclusion of an additional laminate layer in the package may also impact complete de-gassing of the sterilization gas, Ethylene Oxide and may result in a potentially increased risk for patient infection and/or potential exposure | accessdata.fda.gov |
| February 26, 2021 | 87396 | Class II | Ongoing | CF Delivery Dev Caps Bravo x5, FGS-0635/FGS 0636 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age. | The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration of the capsule. In the event of capsule aspiration, immediate intervention to remove the capsule is required. Potential outcomes following capsule aspiration include low oxygen saturation, intervention to retrieve the capsule, potential need to intubate the pati | accessdata.fda.gov |
| January 13, 2021 | 87179 | Class II | Terminated | Covidien Parietex hydrophilic anatomical mesh 15 cm x 10 cm polyester left - Product Usage: designed for the repair of inguinal hernias via laparoscopic or posterior open procedures Item Code: TECT1510AL | incorrect device is contained in the package. The packaging label indicates that the device is for left side use, the product inside the package is for right side use. Use of an opposite side mesh can result in implant failure and hernia recurrence | accessdata.fda.gov |
| November 23, 2020 | 86886 | Class II | Completed | Covidien TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue. Item Number: TA30V3S | May contain a damaged internal component which could impede staple deployment and result in incomplete staple formation and a non-functional staple line preventing adequate hemostasis, or leading to anastomotic leak, pneumothorax, tissue damage or other delayed secondary complications including infection, peritonitis, and sepsis | accessdata.fda.gov |
| November 16, 2020 | 86829 | Class II | Ongoing | Capnostream 35 Portable Respiratory Monitor, Product numbers PM35MN02, PM35MN01, PM35MN05, DLPM35MN02 - Product Usage: use during both no motion and motion conditions and for patients who are well or poorly perfused. | The firm has released software update V01.05.02.16 (also known as V1.5.2) in response to customer reports of a false display of the message, "Temperature Exceeds Limits" followed by automatic shutdown of the monitor with no accompanying alarm. | accessdata.fda.gov |
| October 16, 2020 | 86643 | Class II | Ongoing | Puritan Bennett 980 (PB980) Ventilator Series - Product Usage: for use on patient population sizes from Neonatal (NICU) through Adult who require respiratory support or mechanical ventilation SKU: 980X1ENDIUU 980X1ENDIUU | In-house lab observations and customer reports of overheating and/or thermal damage to the battery pack, create the risk of exposure to smoke or hazardous materials, which may result in burns and/or bronchospasm | accessdata.fda.gov |
| June 26, 2020 | 86001 | Class II | Ongoing | Beacon EUS Access System Preloaded Access 90degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula intended to pierce ti | This voluntary recall is being conducted following three customer reports of the device cannula detaching during a procedure. In one case, the detached cannula was not retrieved during the procedure. Potential risks associated with a detached cannula include delay in treatment, biliary leak, pain and retained device fragments. | accessdata.fda.gov |
| May 12, 2020 | 85689 | Class II | Ongoing | Multifire VersaTrack Auto Suture Hernia Stapler, 4.0mm, Part No. 174021 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgica | The product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly advance within the staple cartridge when the instrument handle is compressed. | accessdata.fda.gov |
| April 30, 2020 | 85629 | Class II | Terminated | Dover 100% Silicone Foley Catheter with Temperature Sensor 14FR 5CC2W, Product Code: 50514T - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only. | Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2C. Failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment | accessdata.fda.gov |
| February 10, 2020 | 84991 | Class II | Terminated | Covidien Force TriVerse Electrosurgical Devices, Product numbers FT3000 and FT3000DB, UDI 10884524000084 20884524000081; 10884524001937 20884524001934 | Sterile packaging may potentially be compromised, and use of products may result in increased risk for infection. | accessdata.fda.gov |
| January 17, 2020 | 84811 | Class II | Terminated | Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery Item Code: EGIAUSTND | Potential for the sterile barrier to be compromised. Products with a compromised sterile barrier may result in a potentially increased risk for infection | accessdata.fda.gov |
| April 29, 2019 | 82802 | Class II | Terminated | MAHURKAR and Argyle acute hemodialysis catheters, Material numbers 8813793009 8813793013 8813794005 8813794009 8813816005 8813816009 8813817005 8813817009 8815668007 8815668011 8815668021 8815668027 8817142005 8817143005 | The priming volume values printed on the MAHURKA and Argyle acute catheters and Instructions for Use (IFU) are higher than the volumes required to fill each lumen. | accessdata.fda.gov |
| March 13, 2019 | 82426 | Class II | Terminated | Covidien Endo Clinch II Auto Suture Grasper, 5mm REF: 174317 The Covidien Endo Clinch" II Auto Suture" grasper 5mm has a 5 mm diameter, rotating, insulated shaft approximately 31 cm in length and is designed for introduc | Sterilization method used was not consistent with the labeling and the approved sterilization method | accessdata.fda.gov |
| February 15, 2019 | 82245 | Class II | Terminated | Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736 | The product does not meet sterility requirements. Product labeled as sterile was distributed without undergoing sterilization prior to distribution. | accessdata.fda.gov |
| November 5, 2018 | 81607 | Class II | Terminated | 8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), Model Number 36826 | The product was released into commercial distribution while subject to importation refusal. | accessdata.fda.gov |
| October 31, 2018 | 81560 | Class II | Terminated | Salem Sump Dual Lumen Stomach Tube 10 Fr/Ch (3.3 mm) x 36" (91 cm), Product Code 8888264911 Product Usage: The Salem Sump Tubes are intended for decompression and drainage of stomach contents following injury, illness, o | This voluntary recall is being conducted due to incorrect packaging. In one lot of Salem Sump Dual Lumen Stomach Tubes the 10Fr product was packaged in a 16Fr pouch. The use of a 10 Fr Salem Sump Tube when a 16Fr is needed could result in decreased fluid collection, with the potential to affect patient care, particularly in an emergency situation where the c | accessdata.fda.gov |
| September 18, 2018 | 81167 | Class I | Terminated | Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett" 980 Pediatric Adult Ventilator Puritan Bennett" 980 Neonatal Ventilator Puritan Bennett" 980 Universal Ventilator Product Usage: The Puritan Bennett 980 Ser | Software Update: External USB Drive performance and its impact on Graphic User Interface (GUI) functionality and labeling of the scalar waveform displayed on GUI during ventilation | accessdata.fda.gov |
| August 17, 2018 | 81043 | Class II | Terminated | EEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT TRIEEA28XT TRIEEA31MT TRIEEA31XT Product Usage: The EEA Circular Stapler with Tri-Staple Technology places a circular, triple staggered row of titanium | The firm identified the potential for a device to have an incorrect tissue gap. Use of a device with an incorrect tissue gap may result in incomplete staple formation and/or the inability to remove the device from tissue following application potentially leading to bleeding, anastomotic leak or tissue trauma. There have been no reports of serious injury rela | accessdata.fda.gov |
| August 1, 2018 | 80924 | Class II | Terminated | Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization w | Potential for product sterility breach due to a compromised or pinched seal defect | accessdata.fda.gov |
| July 11, 2018 | 80747 | Class II | Terminated | 400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16XTSD | The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient. | accessdata.fda.gov |
| October 24, 2017 | 79352 | Class II | Terminated | Argyle Suction Tubing (Product # 8888301515) Argyle Suction Tubing is an extruded tube used as an extension for different types of devices in an operating room, bonded with 2 female sure grip connectors at each end of th | Incorrect packaging. In one lot of Argyle Suction Tubing, the pouch may be incorrectly labeled as the Salem Sump Dual Lumen Stomach Tube. This product may have been distributed within the case of Argyle Suction Tubing. | accessdata.fda.gov |
| October 14, 2017 | 79319 | Class II | Terminated | MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays. Product Number: 8888222316. | Medtronic is voluntarily recalling one lot of its MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays, Lot 1717900160, following notification from our supplier that one production lot of MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays was inadvertently shipped to | accessdata.fda.gov |
| April 28, 2015 | 71138 | Class II | Terminated | VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402. For vascular use. | Possible sterility breach of the outer packaging (pouch) material which may compromise the outside surface sterility of the sealed inner tray. | accessdata.fda.gov |
| September 18, 2014 | 69257 | Class I | Terminated | Covidien Medi-Trace Cadence and Kendall Adult Multi-Function Defibrillation Electrodes, Radiotransparent Part Number: 22660R | Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs Defibrillators | accessdata.fda.gov |
| May 8, 2014 | 68243 | Class II | Terminated | Devon Supine, Lithotomy and Trendelenburg Positioning Kit; Product Code: 31151090 Product Usage: The device is intended to provide padding under the patient, and help maintain the position of an anesthetized patient duri | Straps may separate from the foam pad. | accessdata.fda.gov |
| August 16, 2013 | 65978 | Class II | Terminated | Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 10 mL Fill Product ID: 8881570121 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, sin | Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin | accessdata.fda.gov |
| April 12, 2013 | 64908 | Class III | Terminated | Curity I.V. Start Kit, Product ID: 80530 and Curity I.V. Start Kit Product ID: 8508. IV Start Kit. | On March 26, 2013 Covidien received a recall notice from one of their suppliers CareFusion. CareFusion is recalling a variety of OTC drug products including the 10% Povidone Iodine SEPP Applicator which is utilized in specific convenience kits. | accessdata.fda.gov |
| April 8, 2013 | 64868 | Class II | Terminated | Medi-Trace Cadence Adult Radiotransparent Defibrillation Electrode Product ID: 22550R. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures. | Defibrillation Electrodes may arc/spark result in thermal damage to the leadwire, which could render the device incapable of delivering the appropriate energy or shock to the patient | accessdata.fda.gov |
| May 21, 2012 | 61908 | Not yet classified | Terminated | Monoject Insulin Safety Syringe 3/l0mL 29 X 1/2" Product ID: 8881511144 Indications for Use: Injection of U-1 00 insulin | Safety shield may separate from the syringe, exposing the needle, which could potentially result in a needle stick | accessdata.fda.gov |
| April 29, 2011 | 58665 | Not yet classified | Terminated | URI-DRAIN Medium Male External Catheter With Two-Sided Adhesive Strap and Skin Protective Wipe Product ID: 8884732000 Intended use: Collector urine from male patients (and accessories) for indwelling catheter | A component of the Uri-Drain device recalled the Skin-Prep (manufactured by H&P Industries-Triad) a protective wipe due to bacterial contamination | accessdata.fda.gov |
| November 15, 2010 | 57315 | Not yet classified | Terminated | MONOJECT Prefill Heparin Lock Flush Syringe 10 Unit Heparin, 10 ml in 12 ml syringe Item code 8881580121 | The heparin sodium USP used to manufacture was produced with crude heparin containing Over-Sulfated Chondroitin Sulfate. | accessdata.fda.gov |
| November 15, 2010 | 57314 | Not yet classified | Terminated | MONOJECT Blood Collection Tubes containing heparin 13x100 sodium heparin trace element Item Code 8881307014 | The heparin sodium USP used to manufacture blood collection tubes was produced with crude heparin containing Over-Sulfated Chondroitin Sulfate. | accessdata.fda.gov |
| August 11, 2010 | 56565 | Not yet classified | Terminated | AVI Sterile Impad Rigid Sole Foot Cover, Right Foot Product Code:6066 | Covidien issued an Urgent Product Recall of the Sterile ImPad Rigid Sole Foot Cover. The product is indicated for prevention of blood pooling in the limb. 120 cases of each Lot code 6066 (right foot) and 6067 (left foot) were shipped to the distributor before sterilization. The customer is instructed to quarantine the product and return it to the manufacture | accessdata.fda.gov |
| October 9, 2008 | 49606 | Not yet classified | Terminated | ReliOn Insulin syringes - 1cc, 31 G Distributed by: Can-Am Care, Corp., Alpharetta, GA | Mislabeled: Package labeled as an insulin syringe for use with U-100 insulin contains an insulin syringe for use with U-40 insulin. Risk of overdose of insulin. | accessdata.fda.gov |
| March 28, 2008 | 47436 | Not yet classified | Terminated | Tyco Healthcare Monoject Prefill 10U/rnL Heparin Lock Flush Syringe, 10ml, REF # 8881580121, Tyco Healthcare, Mansfield, MA 02048 | Scientific Protein Laboratories (SPL), disclosed that two lots of Heparin Sodium, USP Active Pharmaceutical Ingredient has a heparin-like contaminant. | accessdata.fda.gov |
| April 27, 2005 | 32022 | Not yet classified | Terminated | Tyco Healthcare Kendall Argyle Neonatal Pediatric PICC, 1.9 Fr/Ch x 30 cm Dual Lumen PICC Catheter, REF 43304. A single catheter in a thermoformed tray with a Tyvek lid. The lidded tray is packaged one per carton. Firm o | Holes in thermoformed tray compromising the sterility of the product. | accessdata.fda.gov |
| October 8, 2004 | 30196 | Not yet classified | Terminated | Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 20G X 1 inch Product Code: 8881833010 | Needle cannula may separate from the hub during use | accessdata.fda.gov |
| January 8, 2004 | 28090 | Not yet classified | Terminated | Kendall Kerlix A.M.D. Antimicrobial Large Roll, Sterile 6 ply-4.5 in x 4.1 yd Product Number: 3331 | Sterility compromised due to lack of package seal integrity | accessdata.fda.gov |
| December 2, 2003 | 27842 | Not yet classified | Terminated | Mahurkar QPlus Dual Lumen Catheter Kit with Curved Extension, 13.5 Fr/Ch x 19.5cm For hemodialysis, apheresis, and infusion. Reference: 8888-135192 | Product is mislabeled to catheter length. Product labeled as a 13.5 Fr x 19.5 cm may contain a 13.5Fr x 16.0 cm | accessdata.fda.gov |
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Updated October 29, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.