Recall Z-0719-2020 ยท KGX Tape And Bandage, Adhesive
3M Company - Health Care Business
3M Durapore Advanced, Surgical Tape, Model Numbers: 1590-0, 1590-1, 1590-2, 1590-3, 1591-0, 1591-1, 1591-2, 1591-3, 1590S-1, 1590S-2, 1590B-118, 1590B-136
| Date | Nov 21, 2019 |
| Status | Terminated |
| Reason | While the product meets all safety and efficacy criteria, long term exposure of 3M Durapore Advanced Surgical Tape to continuous high moisture clinical applications has not fully met all of 3M s performance expectations. This use environment may cause tape bond failure, leading the tape to not perform as intended. Further, the tape fibers may fray which could be accidentally ingested or aspirated. |
| Root cause | Device Design |
| Action | The firm initiated the recall by letter on 11/20/2019. The letter explained the failures seen and requested the following actions be taken: 1. Immediately cease use of the product and quarantine it for destruction/disposal. 2. Complete the attached Customer Acknowledgement Form with the following: - Acknowledge that you have read and understood this letter whether or not you have any 3M" Durapore" Advanced Surgical Tape in stock at your facility; and - Indicate if you have any product in stock and dispose of this material per facility policy. - Email the completed form to 3Mhealthcar |
| Quantity | 470,954 rolls |
| Distribution | Nationwide, Canada, Germany, France, Switzerland, Denmark |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.