Recall Z-1936-2010 ยท FKG Tray, Start/Stop (Including Contents), Dialysis
Centurion Medical Products
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
| Date | Jun 30, 2010 (initiated Mar 16, 2010) |
| Status | Terminated |
| Reason | The 3M micropore tape is under recall due to the tape not performing and needles becoming loose and dislodged. |
| 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 co |
| Quantity | 3144 kits |
| Distribution | Nationwide Distribution -- AR and OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.