Data / Medical devices / United States / Centurion Medical Products, LP
Centurion Medical Products, LP: FDA-registered device maker in Howell, MI, United States, 7 510(k) clearances
Centurion Medical Products, LP is registered with the FDA (registration 1824619) in Howell, MI, United States. It lists 61 device types. The FDA files 7 510(k) clearances under its listings, the newest dated May 24, 2022. 13 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1824619
- Address
- 301 Catrell Dr, Howell, MI, United States, 48843
- Owner or operator
- Medline Industries, LP (1824619)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- August 21, 2001
- Registered through
- 2027
- Brand names listed
- Centurion, Centurion CirClamp, Centurion Kits, HUBGUARD, Medline Cardiovascular Procedure Kits, Medline General Surgery Tray, Medline Integrated Arterial Catheter, SECUREVIEW 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 |
|---|---|---|---|---|---|---|
| May 24, 2022 | K213481 | Medline General Surgery Tray | LRO | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| May 17, 2022 | K210548 | Medline Integrated Arterial Catheter | DQX | Substantially Equivalent | Centurion Medical Products | accessdata.fda.gov |
| December 3, 2021 | K212258 | Medline Cardiovascular Procedure Kit | LRO | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| May 18, 2012 | K113565 | MULTI-MED CENTRAL VENOUS CATHETERS (CVCS), WITH AND WITHOUT HEPARIN VANTEX CENTRAL VENOUS CATHETERS (CVCS), WITH HEPARIN | FOZ | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| August 28, 2008 | K080448 | CENTURION PROTECTIVE RESTRAINT, SCR SERIES | FMQ | Substantially Equivalent | Tri-State Hospital Supply Corp. | accessdata.fda.gov |
| August 9, 1989 | K885179 | INTRO-FLEX SHEATH INTRODUCER W/AMC THROMBOSHIELD | DYB | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| March 28, 1989 | K890897 | CENTURION CIRCLAMP | HFX | Substantially Equivalent | Tri-State Hospital Supply Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 28, 2013 | 66830 | Class II | Terminated | Centurion Sterile # 84 Rubber Bands Reorder EB84, Caution: This product contains natural rubber latex which may cause allergic reactions. LATEX FREE, CAUTION: FEDERAL lAW (USA) RESTRICTS THIS DEVICE TO SALE BY OR ON THE | Package labeling indicates both "latex free" and "contains natural rubber latex". The rubber bands do contain natural rubber latex. This could cause a significant risk to users with latex allergies. | accessdata.fda.gov |
| December 6, 2010 | 57661 | Not yet classified | Terminated | VAD Kit Reorder DT8915, Sterile, Centurion Medical Products Corp. Williamston, MI Intended use: Vascular access port kit | The firm is conducting a recall of kits that contain the MONOJECT PREFILL ADVANCED flush syringes containing heparin. The syringes are under recall by their manufacturer Coviden because of testing that showed "that the crude heparin used to produce a specific batch of purified heparin sodium USP contained low level of Over-Sulfated Chondroitin Sulfate (OSCS) | accessdata.fda.gov |
| June 2, 2010 | 56391 | Not yet classified | Terminated | Centurion Medical Products Central line procedure tray, CVI3070, Sterile. | The kits contain heparin lock flush solution USP code 504505 that is under recall by APP Pharmaceuticals. APP Pharmaceuticals is recalling the heparin because of incomplete documentation associated with test results. | accessdata.fda.gov |
| April 9, 2010 | 55305 | Not yet classified | Terminated | Basic Core Pack # OR1805, Sterile, Tri State Hospital Supply Corporation Manufacturers of Centurion Healthcare Products. | The firm is conducting a sub recall of kits containing ConMed Goldline Rocker Switch Pencils. The pencils activation switch may remain in the "on" position after the switch has been depressed with excessive force, thereby continuously activating the pencil. | accessdata.fda.gov |
| March 16, 2010 | 55885 | Not yet classified | Terminated | Dialysis On/Off Kit, DT11300, Sterile, Micropore Surgical Tape, Single Use Rolls, Port Access Dressing Change Tray, Tri-State Hospital Supply Company Manufacturers of Centurion Healthcare Products Howell, MI | The 3M micropore tape is under recall due to the tape not performing and needles becoming loose and dislodged. | accessdata.fda.gov |
| February 1, 2010 | 54623 | Not yet classified | Terminated | Centurion Healthcare Products Pump Fill Kit DT10175. CONTENTS: 1 CSR WRAP, 2 GLOVES, 1 FENESTRATED DRAPE, 1 EXTENSION LINE Approx. Priming Vol.: 0.3mL, 1 SYRINGE, 1 Exel Huber NEEDLE, 1 ChloraPrep(R), 1 TRAY The recalled | A supplier notified this firm of a recall of their Huber needles because the needles that are labeled as non-coring could core 60-72% of the time. Centurion is doing a sub recall of their kits that contain the referenced needles. | accessdata.fda.gov |
| September 22, 2009 | 53550 | Not yet classified | Terminated | Tri-State Hospital Supply Corp., Centurion Healthcare Products Premie Packs, 50, sterile, Tri-State Hospital Supply Corp., Howell, MI; code no. LM110. Aspiration tray containing Portex uncuffed pediatric sized tracheal t | The pediatric tracheal tubes used in these kits were manufactured with an internal diameter smaller than indicated in the label, which could result in an inability to remove secretions and cause partial or complete obstruction of the airway. | accessdata.fda.gov |
| January 14, 2009 | 51439 | Not yet classified | Terminated | Tri-State Centurion Endoscopy Tray, sterile, 10 per case, Tri-State Hospital Supply Corp., Howell, MI; Reorder MNS4635. | Compromised sterility, as the package seals may be inadequate. | accessdata.fda.gov |
| January 14, 2009 | 50867 | Not yet classified | Terminated | Tri-State Centurion Chest Tube Insertion Tray, sterile, 6 per case, Tri-State Hospital Supply Corp., Howell, MI.; Reorder CHT620. | Lack of assurance of sterility, as the package seals may be inadequate. | accessdata.fda.gov |
| April 8, 2008 | 52130 | Not yet classified | Terminated | Tri-State Hospital Supply Corp., Tri-State Centurion Venous Access Port Kits, Qty/case 20, sterile, Code No./Reorder KNV80. Each kit contains 1 sterile heparin flush injection solution as follows: Tyco Healthcare Monojec | The kits contain Monoject prefill heparin lock flush syringes, which were recalled by the manufacturer due to contamination. | accessdata.fda.gov |
| October 26, 2007 | 46155 | Not yet classified | Terminated | Centurion Healthcare Products Laceration Tray, sterile; (Reorder SUT8805A) Tri-State Hospital Supply Co., Howell, MI 48844. The primary kit is labeled as containing 1 needle, 21G x 1-1/2", among other components, however | Incorrect Needle size - Some of the kits contain a 1 inch 21G needle instead of the 1-1/2 inch 21G needle specified on the kit label. | accessdata.fda.gov |
| April 12, 2005 | 31645 | Not yet classified | Terminated | Centurion brand CirClamp with 1.3 cm bell, sterile, single use; product 330. | Lot 11224 may contain a 1.1 cm clamp and bell and neither lot is labeled as reprocessed, when they have been reprocessed. | accessdata.fda.gov |
| March 8, 2005 | 31323 | Not yet classified | Terminated | Centurion brand sterile Huber needle infusion set, 20 GA x 1 inch; product EXHN010S. | Some of the needles in these sets are 3/4 inches in length instead of the labeled 1 inch. | accessdata.fda.gov |
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Updated May 24, 2022. 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.