Z-1937-2010
C.A.P.D. Tubing Exchange Tray, HT80, Sterile, Micropore Surgical Tape, Single Use Rolls, Tri-State Hospital...
Centurion Medical Products, LP / initiated 2010-03-16 / Terminated
Centurion Medical Products began a recall of C.A.P.D. Tubing Exchange Tray, HT80, Sterile, Micropore Surgical Tape, Single Use Rolls, Tri-State Hospital Supply Company Manufacturers of Centurion... 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-1937-2010
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Centurion Medical Products, LP
- Product
- C.A.P.D. Tubing Exchange Tray, HT80, 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
- 24 kits
- Distribution
- Nationwide Distribution -- AR and OH.
- Product codes and lots
- 801218, 802188, 2009080380 and 2009081080.
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What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
