Recall Z-1419-2010 ยท KGX Tape And Bandage, Adhesive
3M Company / Medical Division
3M Micropore Paper Tape, Cat. No. 1530-254, 2 in x 54 in., 400 rolls / case.
| Date | Apr 20, 2010 (initiated Jan 29, 2010) |
| Status | Terminated |
| Reason | Reduced adhesion: Micropore Surgical Tape for use as the primary securement device for 1) dialysis needles used to access A-V fistulas or grafts; or 2) pressure dressings used after dialysis treatments. If the tape does not perform, the dialysis needle may loosen and could then dislodge. In the interim, please offer 3M Micropore Surgical Tape, 1 inch x 10 yard rolls (CAT #1530-1) as a substitutio |
| Root cause | Nonconforming Material/Component |
| Action | An Urgent Medical Device Recall letter was sent to 3M customers beginning 01/29/2010. The letter described the issue, asked distributors to check existing inventory, quarantine affected lots. Distributors were asked to notify their customers and end-users (3M has provided example letters and return forms to facilitate). End users can return product either to the distributor or contact 3M directly. A Product Recall Form is asked to be faxed back to 3M. A second 3M "Urgent Medical Device Recall" letter dated February 22, 2010 was sent to customers. This letter informed the cusotmers that 3M |
| Quantity | 20,400 |
| Distribution | Nationwide distribution, and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.