Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1938-2010

Dialysis Tray, SP560, Sterile, Micropore Surgical Tape, Single Use Rolls, Tri-State Hospital Supply Company...

Centurion Medical Products, LP / initiated 2010-03-16 / Terminated

Centurion Medical Products began a recall of Dialysis Tray, SP560, Sterile, Micropore Surgical Tape, Single Use Rolls, Tri-State Hospital Supply Company Manufacturers of Centurion Healthcare Products... on . The reason FDA records is "The 3M micropore tape is under recall due to the tape not performing and needles becoming loose and dislodged". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1938-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Centurion Medical Products, LP
Product
Dialysis Tray, SP560, Sterile, Micropore Surgical Tape, Single Use Rolls, Tri-State Hospital Supply Company Manufacturers of Centurion Healthcare Products Howell, MI
Product code
FKG Tray, Start/Stop (Including Contents), Dialysis
Reason for recall
The 3M micropore tape is under recall due to the tape not performing and needles becoming loose and dislodged.
FDA root cause
Other
Action
The firm sent Urgent Recall Product Notices to its two customers dated 3/16/2010. The letter explained that the tape may not adhere properly. The consignees were instructed to remove any kits containing the recalled tape from their inventory, if the tape was used to secure dialysis needles or pressure dressings. If the tape was used for other purposes, the kits could still be used. The recall letter included a reply form for customers to complete and email or fax back. Upon receipt of the form, a Centurion Representative will contact them to retrieve affected product. Customers should contact Matthew Price at 517-546-5400 ext. 1135, if further info is needed.
Quantity in commerce
144 kits
Distribution
Nationwide Distribution -- AR and OH.
Product codes and lots
912317, 902048, 2008112490, 2009020290, 2009062290 and 2009070690.