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U.S. Department of Health and Human Services

Medical Devices

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Tri-State Hospital Supply Corporation - Centurion Trays and Kits

Recall Class:
Class I
Date Recall
Initiated:
January 14, 2009
Products and Uses:
  • Tri-State Centurion Chest Tube Insertion Tray (CHT620), Lot # 2008111350
    • Tray is for holding devices needed for a chest tube insertion.
  • Tri-State Centurion Chest Tube Insertion Tray, Dentry/Bardmoor (CHT505), Lot # 2008111350
    • Tray is for holding devices needed for a chest tube insertion.
  • Tri-State Centurion PICC Line Tray (CVI2370), Lot # 2008111050
    • Tray is for holding a Peripherally Inserted Central Catheter (PICC) line.
  • Tri-State Centurion PICC Insertion Tray (CVI2415A), Lot # 2008111150
    • Tray is for holding devices needed for a PICC insertion procedure.
  • Tri-State Centurion PICC/CVC Insertion Tray (CVI2490), Lot # 2008111850
    • Tray is for holding devices needed for a PICC or Central Venous Catheter (CVC) insertion procedure.
  • Lee Medical Neonatal/Ped PICC Insertion Tray (CVI1025), Lot # 2008111750
    • Tray is used to hold devices needed for a PICC insertion procedure for a newborn or for a child.
  • Tri-State Centurion Port Access Kit (KNV35), Lot # 2008111150
    • Kit is used for holding accessories in a port access procedure (The port is a small device with a hollow space that allows access to a body cavity or blood vessel).
  • Tri-State Centurion Port Access Tray (DT4825), Lot # 2008111250
    • Tray is used to hold accessories in a port access procedure.
  • Tri-State Centurion Port Access Tray (DT5245), Lot # 2008111250
    • Tray is used for holding accessories in a port access procedure.
  • Tri-State Centurion Port Access Tray (KNV75), Lot # 2008111450
    • Tray is used for a port access procedure.
  • Tri-State Centurion Implanted Access Port Tray (DT7105), Lot # 2008110650
    • Tray is used for holding accessories for an implanted port access procedure.
  • Tri-State Centurion Sutureless Multi-Lumen CVC Insertion Kit (ECVC175), Lot # 2008111250
    • This kit is used for insertion of a multi-lumen (one tube containing multiple passage ways), central venous catheter procedure.
  • Tri-State Centurion Umbilical Vessel Tray without Catheter (UVT170), Lot # 2008111050
    • Tray is for keeping accessories used in a port access procedure.

These products were manufactured from November 17, 2008 through November 21, 2008 and distributed from November 24, 2008 through January 7, 2009.

Recalling Firm:
Tri-State Hospital Supply Corporation
301 Catrell Drive
Howell, Michigan 48843
Reason for Recall:
The weak package sealing may affect the sterility of the devices.
Public Contact:
The company may be contacted at 1-800-248-4058.
FDA District:
Detroit
FDA Comments:

The company sent their distributors and customers a recall notice on January 14, 2009. They were instructed to:

  • remove the products from their inventory
  • inform the company of the number of products in stock
  • hold the products until the company arranges for their return

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA's MedWatch Adverse Event Reporting program.  Use the nearby link to MedWatch.