Data / Medical devices / United States / B. Braun Us Device Manufacturing LLC
B. Braun Us Device Manufacturing LLC: FDA-registered device maker in Allentown, PA, United States, 30 510(k) clearances
B. Braun Us Device Manufacturing LLC is registered with the FDA (registration 2523676) in Allentown, PA, United States. It lists 57 device types. The FDA files 30 510(k) clearances under its listings, the newest dated September 15, 2022. 58 recall events name it as the recalling firm (4 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2523676
- Address
- 901 Marcon Blvd, Allentown, PA, United States, 18109
- Owner or operator
- B. BRAUN MEDICAL INC. (9925035)
- Roles
- Contract manufacturer, Contract sterilizer, Repackager or relabeler
- First device listed
- August 27, 1992
- Registered through
- 2026
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 |
|---|---|---|---|---|---|---|
| September 15, 2022 | K211204 | SafePort(TM) Manifold (or Stopcock) | FMG | Substantially Equivalent | Elcam Medical Acal | accessdata.fda.gov |
| June 27, 2014 | K133632 | PERICAN ULTRA | BSP | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| May 21, 2013 | K122735 | SORIN VASCULOOP TWO TIE ENDOSCOPIC LIGATION SYSTEM MODEL DTTS2 | GAT | Substantially Equivalent | Sorin Group USA, Inc. | accessdata.fda.gov |
| November 20, 2012 | K121846 | CONTIPLEX C CONTINUOUS PERIPHERAL NERVE BLOCK NEEDLE | BSP | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| December 22, 2011 | K112515 | PENCAN SPINAL NEEDLE | BSP | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| June 10, 2011 | K103736 | DMC MEDICAL SINGLE-USE POLYCARBONATE SYRINGE | FMF | Substantially Equivalent | Dmc Medical, Ltd. | accessdata.fda.gov |
| June 9, 2011 | K111016 | SAFEPORT MANIFOLD (TM) (OR STOPCOCK) | FPA | Substantially Equivalent | Elcam Medical Acal | accessdata.fda.gov |
| April 16, 2010 | K100241 | CONTIPLEX D CONTINUOUS NERVE BLOCK SET, MODEL 331687, 331686, 331685, 331680 | BSP | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| June 29, 2009 | K090884 | PERIFIX ONE PEDIATRIC CATHETER, 20 GA. & 24 GA. | BSO | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| April 13, 2006 | K060231 | CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCK | FMG | Substantially Equivalent | Elcam Medical Acal | accessdata.fda.gov |
| January 24, 2006 | K052773 | B. BRAUN 0.2 MICRON FILTER | FMF | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| November 17, 2005 | K052313 | STIMUPLEX HNS-12, MODEL 4892098 | BXN | Substantially Equivalent | Stockert GmbH | accessdata.fda.gov |
| September 30, 2004 | K042488 | PERIFIX CATHETER AND CONTIPLEX CATHETER | BSO | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| February 4, 2004 | K033952 | PERIFIX CATHETER CONNECTOR | CAZ | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| October 1, 2003 | K032144 | PERIFIX CATHETER CONNECTOR | CAZ | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| September 12, 2003 | K032393 | INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK) | FMG | Substantially Equivalent | Elcam Medical Acal | accessdata.fda.gov |
| October 18, 2002 | K022895 | ELCAM STOPCOCKS AND MANIFOLDS | FMG | Substantially Equivalent | Medical Device Consultants, Inc. | accessdata.fda.gov |
| March 27, 2002 | K013949 | UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTOR | FPA | Substantially Equivalent | Churchill Medical Systems, Inc. | accessdata.fda.gov |
| March 6, 2001 | K002689 | SWABSITE SWABBABLE VALVE, MODEL 245000 | FPA | Substantially Equivalent | Quest Medical, Inc. | accessdata.fda.gov |
| January 28, 1997 | K964352 | TORQUE DEVICE | DQX | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| August 2, 1995 | K945965 | ATRAUMATIC PENCIL POINT SPINAL NEEDLE | BSP | Substantially Equivalent | Avid N.I.T., Inc. | accessdata.fda.gov |
| June 21, 1995 | K942391 | BRAUN MANIFOLD | DTL | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| January 26, 1994 | K932569 | PENCIL POINT SPINAL NEEDLE AND TRAY | BSP | Substantially Equivalent | B. Braun of America, Inc. | accessdata.fda.gov |
| May 6, 1986 | K861288 | NON-STERILE & STERILE DISPOSABLE SURGICAL DRAPES | KKX | Substantially Equivalent | Procedure Pak, Inc. | accessdata.fda.gov |
| December 19, 1985 | K854816 | EPIDURAL ANESTHESIA NEEDLES | BSP | Substantially Equivalent | Reganes, Inc. | accessdata.fda.gov |
| February 26, 1985 | K850326 | STERILE FILM DRAPE FENESTRATED W/ADHESIVE PATCH | KKX | Substantially Equivalent | Excel Health Care Products | accessdata.fda.gov |
| September 7, 1984 | K843414 | TOP HYPODERMIC SYRINGE PISTON | FMF | Substantially Equivalent | Top Surgical Manufacturers Co. | accessdata.fda.gov |
| December 3, 1981 | K813179 | PERICAN, EPIDURAL CANNULA | BSP | Substantially Equivalent | Burron Medical Products, Inc. | accessdata.fda.gov |
| December 3, 1981 | K813165 | PLEXUFIX BRACHIAL PLEXUS ANESTH. NEEDLE | BSP | Substantially Equivalent | Burron Medical Products, Inc. | accessdata.fda.gov |
| November 2, 1976 | K760383 | STOPCOCKS | KGZ | Substantially Equivalent | B. Braun Instruments | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 4, 2024 | 95874 | Class II | Ongoing | Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of analgesic/anesthetic agent to intrathecal space and epidural space for pain control. Model/Catalog Number: 530159 | Incorrect catheter connector within the kit resulting in inability to provide a secure connection to the epidural catheter. The incorrect catheter connector is smaller than the required catheter connector and therefore is unable to be used to administer medication. | accessdata.fda.gov |
| August 8, 2024 | 95153 | Class II | Ongoing | AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way Stopcock, Model/Catalog Number: 472036 | Potential for product leakage from the Spin Lock Connector on the distal end of the device due to the migration of excess solvent during the assembly process. | accessdata.fda.gov |
| June 17, 2024 | 94823 | Class II | Ongoing | OUTLOOK IV SET 15DROP W/2 CARESITE-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication. Model/Catalog Number: 354212 | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood. | accessdata.fda.gov |
| January 22, 2024 | 93889 | Class II | Ongoing | Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, PERIFIX FX 19 Ga. Springwound Closed Tip Catheter, 5 mL Glass Luer Lock LOR Tray (Kit)-A collection of devices intended for the administration of an analgesic or a | Kits should contain Filter Straws with Standard Luer Connections however the kits contain Filter Straws with Neuraxial connectors preventing interface with the other components of the kit. | accessdata.fda.gov |
| November 1, 2023 | 93232 | Class I | Ongoing | Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with Caresite Injection Site; 362032 15 drops/mL, priming volume: 22mL, length: 119in, SafeLine; 362033 UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSI | In affected products, the tubing outer diameter may vary in size or the length of tubing may be too short. Both issues may lead to false air-in-line alarms, which will stop the infusion and interrupt therapy. Interruptions or delays in medication administration may result in serious injury to patients which may be life-threatening (e.g. interruption of a vas | accessdata.fda.gov |
| September 26, 2023 | 93074 | Class II | Ongoing | FT1000S FLUID TRANSFER SET, REF No. 356048. For direct transfer of fluids between large volume parenteral solution containers. | Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur requiring additional medical intervention. | accessdata.fda.gov |
| September 21, 2023 | 92978 | Class I | Ongoing | 8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System | Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. Interruption to the infusion of high-risk medications may lead to hemodynamic instability requiring medical intervention to prevent permanent impairment to body structures or body functions. In some cases, this may be life-threatening or may lead to death. | accessdata.fda.gov |
| August 7, 2023 | 92910 | Class II | Ongoing | B. Braun NORM-JECT Luer Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. Distributed by: Air-Tite Products Co., Inc, 565 Central Drive, Virgin | The sterile blister packaging may be damaged, and sterility may be compromised | accessdata.fda.gov |
| July 31, 2023 | 92913 | Class II | Ongoing | Perifix / Epidural anesthesia set, medicated | Product may be mislabeled with an incorrect lid stock label. | accessdata.fda.gov |
| June 5, 2023 | 92523 | Class II | Ongoing | Perifix / Epidural anesthesia kit (10 count carton) | Kits were assembled with the incorrect Filter Straw. | accessdata.fda.gov |
| September 15, 2022 | 90850 | Class II | Ongoing | ULTRASITE US04TL Smallbore T-Port Extension Set, Product Code 474515, 100 units per carton. to provide needle-free access on I.V. and Extension Sets | The extension set has a high probability of failure which could lead to possible leakage or detachment at the device's bonded joint during use. The issue may result in delay of therapy, increased risk of bloodstream infections (BSI), and may expose both patients and healthcare workers to hazardous medications. Depending on the nature of the leak and type of | accessdata.fda.gov |
| January 31, 2022 | 89487 | Class II | Terminated | Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dispensing Pin W/Valve. A valve for aspiration or injection of medication or enteral feeding solution from inverted multi-dose vials. | This lot may have an elevated risk of leakage from the Air-Inlet Filter of the device. Leakage of the Air-Inlet Filter may increase the risk of decreasing the dose of medication delivered to the patient, cause delays in treatment due to the need to replace the device or may cause contamination of the fluid path that can lead to bloodstream infection. | accessdata.fda.gov |
| August 10, 2021 | 88531 | Class II | Terminated | 15 drops/ml, Priming Volume: 27ml, Length: 129 in. Single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluid Material ID: 354212 | Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections. | accessdata.fda.gov |
| June 25, 2021 | 88198 | Class II | Terminated | Infusomat Space Volumetric Pump Administration Set, Product Code 490100 | There is a potential for the Anti-free flow clip of the administration set to be inverted which may cause unintended free flow if the user fails to follow on screen prompt to close the roller clamp prior to set removal from the pump. | accessdata.fda.gov |
| March 15, 2021 | 87585 | Class II | Terminated | Filtered Triple-Leg Extension Set - Intravascular administration set. Product Catalog number: 477034 - Product Usage: The extension set is a sterile, single-use intravascular direct injection, intermittent infusion, cont | BBMI has identified through complaints the potential for the extension set to become occluded or unable to prime. | accessdata.fda.gov |
| November 20, 2019 | 84365 | Class II | Terminated | Outlook Safety Infusion System Y-type Blood Set, Catalog Number 477005 | Potential for leakage at the joint between the blood filters and tubing | accessdata.fda.gov |
| July 10, 2019 | 83478 | Class II | Terminated | ES1725KFXN ESPOCAN SPINAL/EPID TRY NRFIT Catalog # 339114 | The filter capacity is not achieved due to damage of the filter membrane. | accessdata.fda.gov |
| May 1, 2019 | 82966 | Class I | Terminated | B.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog Number 363032 | Potential for the Infusion Pump Administration Set to leak and/or disconnect at the bonded joint between the tubing and Injection Site (Y-Site). | accessdata.fda.gov |
| July 20, 2018 | 80811 | Class II | Terminated | CONTI TUOHY ULTRA 360 2 IN CONT PNB SET, Material Number 331640 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for del | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed. | accessdata.fda.gov |
| June 4, 2018 | 80231 | Class II | Terminated | 26-Lead Transfer Set for use with APEX Compounding System, Product Catalog Number 2112550 | There is a potential for valves on the 26-Lead Transfer Set to be incorrectly oriented. When a transfer set with an incorrectly oriented valve is installed on the system, there is potential for unintended admixture. | accessdata.fda.gov |
| May 9, 2018 | 80142 | Class II | Terminated | Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter, Product Code 363420 The Infusomat Space Pump IV Set, 2 Caresites, ASV with 0.2 Micron Air Eliminating Filter and Anti-Syphon Valve (ASV) is a latex- | There is a potential for a different set to be mixed within the lot, where the incorrect set does not contain an air eliminating filter. | accessdata.fda.gov |
| June 21, 2017 | 78878 | Class II | Terminated | Perifix Continuous Epidural Anesthesia Tray. Product Catalog Numbers: 332075, 332266. Local anesthesia of the skin prior to insertion of the regional anesthesia needle. | B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due tothe presence of loose polypropylene foreign matter was above release specification. This foreign matter has been identified as a product hub material which has been tested for biocompatibility per ISO 10993 during the produ | accessdata.fda.gov |
| July 29, 2016 | 75291 | Class II | Terminated | Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start procedures | Positive results from non-routine sterility testing commissioned by B. Braun Medical Inc. (BBMI) for the finished product of this lot. | accessdata.fda.gov |
| July 11, 2016 | 74879 | Class II | Terminated | Affected Pain Control Tray Component (5% Lidocaine Hydrochloride and 7.5% DExtrose Injection, USP) Injection of anesthetics to provide regional anesthesia | B. Braun Medical Inc. is voluntarily recalling specific lots of their Custom Spinal Anesthesia Tray which contains a drug component, 5% Lidocaine Hydrochloride and 7.5 % Dextrose Injection, USP that Hospira Inc. has recalled because the drug product does not meet the specification for color throughout shelf life. | accessdata.fda.gov |
| April 26, 2016 | 74171 | Class II | Terminated | WHIN Infusion Set - 90 Huber Needle and Wing (22 ga/1in). Intravenous delivery through intravascular ports, 20 units per case, Catalog Number 471734. Usage: Infusion of solution/medication into implanted intravascular po | Potential for the tip of the Huber needle on the WHIN Infusion Set to protrude from the needle guard. | accessdata.fda.gov |
| April 14, 2016 | 73986 | Class II | Terminated | Non-Vented Dispensing Pin with One-Way Valve and Luer Lock Ultrasite Valve Product Usage: Used for aspiration of medication from inverted bags or semi-rigid containers. Interavenous delivery of transferred medication(Dev | BBMI recently identified a potential for a tear in the outer blister packaging on a limited number of units. The tears have been identified in the blister package paper, where the unit label writing is located. | accessdata.fda.gov |
| August 27, 2015 | 72237 | Class II | Terminated | Perifix Continous Epidural Anesthesia Pain Control Trays; Injection of anesthetics to provide regional anesthesia for pain management. | Potential discoloration of the DuraPrep solution from unintended exposure to the sterilant during sterilization performed by the supplier. | accessdata.fda.gov |
| March 27, 2015 | 70870 | Class II | Terminated | CONTIPLEX Continuous Peripheral Nerve Block Tray, CONTIPLEX Stirn Continuous Nerve Block Tray, Custom Epidural and Anesthesia Tray, Custom Epidural Anesthesia Tray, Custom Kit, Custom Single Dose Epidural Anesthesia Tray | There is a potential for a hole to be present in the outer tray of a limited number of pain control trays. This issue may cause the integrity of the sterile barrier to be compromised. A compromised sterile barrier poses a risk of inflammatory response and/or possible contamination of the spinal fluid or epidural space. | accessdata.fda.gov |
| August 6, 2014 | 69054 | Class II | Terminated | B.Braun Accuflo 100ML/H 100ML Elastomeric Infusion Device. AccuFlo devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications. | The primary packaging label (inner pouch label) indicates that the package contents are Catalog Item: CT-1000-250, while the secondary packaging label (outer carton label) indicates the contents are CT-1000-100. The actual contents are a CT-1000-100. | accessdata.fda.gov |
| May 29, 2014 | 68546 | Class II | Terminated | STOPCOCK EXT. SET W/ 3-WAY STOPCOCK WITH INJ. SITE AND SPINLOCK CONNECTOR, 22 inches and 37 inches | Complaints were received that reported the stopcock of some Stopcock Extension Sets are assembled in the reverse position, resulting in the stopcock being closed when set in the open position and vise versa. | accessdata.fda.gov |
| April 3, 2014 | 68040 | Class II | Terminated | Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with Introducer Spinal injection of anesthetics to provide regional anesthesia | B.Braun Medical, Inc. (BBMI) has received reports of 24 gauge Sprotte Needles that are missing the accompanying introducer needles. | accessdata.fda.gov |
| January 8, 2014 | 67236 | Class II | Terminated | SAFSITE Injection Sites and IV Sets manufactured with SAFSITE Injection Sites. A device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. | Complaints were received reporting leakage on certain lots of SAFSITE Injection Sites and IV Sets manufactured with SAFSITE Injection Sites.The SAFSITE Injection Site is intended to provide needle free access on IV and Extension Sets. | accessdata.fda.gov |
| December 13, 2013 | 67172 | Class II | Terminated | B. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML Generally used for delivery of antibiotic and local anesthesia medications. | Internal testing of two lots of the AccuFlo CT-2000-100 Elastomeric Infusion Pump identified flow rates which are outside the specified infusion time and may result in overly rapid infusion of medications. | accessdata.fda.gov |
| September 27, 2013 | 66535 | Class II | Terminated | B. Braun Introcan Safety IV Catheter PUR 24G, 0.7X19mm-US, catalog number 4251601-02. Product Usage: The B. Braun Introcan Safety IV Catheter is a passive anti-stick device to provide venous or arterial access for the in | One lot of Introcan Safety IV Catheters may not contain the anti-needlestick safety clip which is used for the prevention of needlestick injuries. | accessdata.fda.gov |
| August 5, 2013 | 65993 | Class II | Terminated | Outlook Safety Infusion System Burette Set. For intravenous fluid administration. | Reports were received of an incorrectly assembled Outlook Safety Infusion System Burette Set (Product Code 375038), and the investigation determined that one of the ULTRASITE injection sites and corresponding low pressure backcheck valve was assembled upside down. | accessdata.fda.gov |
| April 4, 2013 | 65356 | Class II | Terminated | 20mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC2000 Product is intended for fluid transfer between a Partial Additive Bag (PAB(R)) container and a drug vial. | Possible solution leakage at the interface of the addEASE(TM) Binary Connector (Product Codes BC2000 and BC1300) and the PAB(R) bag. Based on extensive root cause investigation, it has been determined that the leakage is the result of a misaligned cannula (needle) on the addEASE(TM) Binary Connector, which pierces the PAB(R) bag stopper to access the solutio | accessdata.fda.gov |
| March 1, 2013 | 64504 | Class II | Terminated | Diacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367. Intended to filter bacteria and endotoxins from dialysis fluid. | There is the potential of the residual moisture of the Diacap Ultra membrane being reduced over time, which results in the reduction of the membrane permeability (ultrafiltration coefficient). | accessdata.fda.gov |
| March 23, 2012 | 63862 | Class II | Terminated | Space Pump Pole Clamps for the Infusomat Space Pump, model number 8713130. The Pole Clamp is an accessory to Space Pumps designed to support 1 to 3 pumps on a pole. | Firm has become aware of the potential for breakage of the pole clamp locking grids, or rasters, in the Space Pole Clamps. | accessdata.fda.gov |
| March 23, 2012 | 62115 | Class I | Terminated | Infusomat(R) Space Pump (US Version) with software version 686G030103 (commonly termed 'G03'), 686E030003, 686F030005, 686F030007, 686G030002, and 686G030102. Intended for use with adults, pediatrics and neonates and is | Firm became aware of the potential for breakage of the anti free flow clip catch, located on the inside of the pump door, when the IV set anti free flow clip is incorrectly inserted into the pump and the pump door forced closed. If the clip catch is broken and the door opened, free flow protection is still ensured. However, after the set is manually removed | accessdata.fda.gov |
| July 12, 2011 | 60995 | Not yet classified | Terminated | B. Braun Infusomat Space Pump - US Version Infusion pump. Model number 8713050U. | If the IV set anti free flow clip is incorrectly inserted into the pump and the pump door forced closed, the clip catch on the inside of the pump door may break. If the clip catch is broken and the door opened, free flow protection is ensured. If IV set is then removed from pump without closing the roller clamp, the clip may not re-engage the tubing, leaving | accessdata.fda.gov |
| November 24, 2009 | 53955 | Not yet classified | Terminated | Outlook Pump IV Set w/Universal Spike, 2 Injection sites, 1.2um Filter, Pressure limited check valve 111 in V7412F | System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initiation sequence and will not allow the set to be used. This requires a new set to be obtained, thus creating a potential for delay in therapy. | accessdata.fda.gov |
| March 27, 2009 | 51869 | Not yet classified | Terminated | IV Administration Set with Universal Spike, two Ultrasite Injection Sites, Backcheck Valve and Spin-Lock Connector, Catalog # 352049. For use with Secondary Container. | Device defect is occlusion/no flow. | accessdata.fda.gov |
| September 17, 2008 | 49565 | Not yet classified | Terminated | Smallbore T-Port Extension Set with Female Luer Lock Connector and Male Luer Lock T-Port with Ultrasite Injection Site 5 in. The product is shipped 100 units per carton. | Product was assembled incorrectly and connected to the wrong part. | accessdata.fda.gov |
| June 30, 2008 | 49078 | Not yet classified | Terminated | Horizon Pump Set w/150 ml burette w/15 um filter and Ultrasite inj site, 2 Ultrasite inj sites, B/C valve 120 in. Item/Catalog number 375040. The product is shipped 20 units per carton. The product is used with the Horiz | incorrect burette was packaged with the product | accessdata.fda.gov |
| December 10, 2007 | 46348 | Not yet classified | Terminated | Diapact CRRT Assembled Kit HF/HD with Manifold and Standard Spike, item number 7210513. The product is shipped 4 units per shipping carton. Hemodialysis kit, B. Braun Medical, Inc., Allentown, PA 18109 | Faulty tubing does not prime machine as intended. | accessdata.fda.gov |
| July 30, 2007 | 39386 | Not yet classified | Terminated | Normal Saline 3ml in 12ml Syringe. The product is shipped 120 units per carton | Particulate matter in product. | accessdata.fda.gov |
| June 5, 2007 | 38105 | Not yet classified | Terminated | Thermodilution Right Heart Catheters, Catalog Numbers 604028 and 604165. The product is shipped 5 units per carton.-B. Braun Medical, Allentown, Pa. | Cracks at the Catheter Tip | accessdata.fda.gov |
| April 18, 2007 | 37856 | Not yet classified | Terminated | Ultrasite Horizon Pump IV Set. The product is shipped in cases containing 24 sets. | Secondary infusion backs up into primary container. | accessdata.fda.gov |
| April 11, 2007 | 37855 | Not yet classified | Terminated | B.Braun HyperFormer Pump Dispensing Set, Catalog Number V9900-02. The product is shipped in cases containing 10 sets. | The integrity of the sterile product barrier may be compromised | accessdata.fda.gov |
| May 8, 2006 | 35554 | Not yet classified | Terminated | B Braun 9F (O/S) Locking Tearway Introducers non-sterile. Catalog number 614008. The product is packaged as 50 bulk nonsterile units per pouch, 2 pouches per shipping carton. | Mislabeled-9F labeled units actually contain 10F devices | accessdata.fda.gov |
| September 15, 2005 | 33598 | Not yet classified | Terminated | D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage. | package sealing defect - product may not be sterile | accessdata.fda.gov |
| September 1, 2005 | 33892 | Not yet classified | Terminated | 7F Locking Tearaway Introducers non-sterile. Part number 614006. The product is packaged as 50 units per pouch, 2 pouches per carton. | Tear away sheath assembly may contain a sheath (8FR) that is not the correct French size for the dilator (7FR). | accessdata.fda.gov |
| May 27, 2005 | 32210 | Not yet classified | Terminated | Locking Tear-Away Sheath Introducer Product Line. ACCUGUIDE SINGLE LUMEN 4FR PICC P460K 5/; P560K PICC 5FR W/INTRO KIT; MTI451845 4.5FR MINI T/A; MTI551845 5.5FR MINI TA; MTI651845 6.5FR MINI T/A; P460OTW SNGL LUM PICC W | Reports that the tearaway introducer sheaths have cracked hubs/handles and/or improper peeling of the sheath during use. | accessdata.fda.gov |
| May 25, 2005 | 32177 | Not yet classified | Terminated | Right Heart Catheter Product Line: Catalog Number 601129-----5011094 0106 x 1007BBMWS. | Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs. | accessdata.fda.gov |
| July 6, 2004 | 29938 | Not yet classified | Terminated | Standard and Custom Spinal Trays with 5% Lidocaine Hydrochloride 2 ml ampul | drug ampuls in kits contain particulates | accessdata.fda.gov |
| April 16, 2004 | 28911 | Not yet classified | Terminated | 18G Catheter is a component in various kits. | Catheter separated from the hub. | accessdata.fda.gov |
| March 19, 2004 | 28912 | Not yet classified | Terminated | Introcan Safety IV Catheter 22G x 1'' PUR with Wings. The affected catalogs and lot numbers: Catalog Number 4253540 - Lot number 3G26258U02 Catalog Number 4253540 - Lot number 3G27258U02 | Mislabeled product. The recalling firm received a complaint that a box of Introcan Safety Catheters, (22G x 1 inch) contained mixed 18G catheters with the same lot number. | accessdata.fda.gov |
| April 14, 2003 | 26226 | Not yet classified | Terminated | Gravity and Infusion Pump Intravenous (IV) Sets using the Y-site Ultrasite Valve including: Horizon Pump IV Sets; Vista Pump IV Sets; Primary IV Sets; Blood Sets; Burette Sets; Filtered Administration Sets; Extension Set | possible leakage | accessdata.fda.gov |
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- All makers of Set, I.V. Fluid Transfer
- All makers of Dressing Change Tray
Updated January 24, 2025. 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.