Recall Z-1633-2024 ยท KGX Tape And Bandage, Adhesive
3M Company - Health Care Business
3M Durapore Surgical Tape, Catalog Number 1538-118
| Date | Apr 24, 2024 (initiated Mar 20, 2024) |
| Status | Open, Classified |
| Reason | Select lots of the 3M Durapore Surgical Tape, Catalog Number 1538-118, were incorrectly labeled with a shelf life of 5 years, rather than 3 years. |
| Root cause | Error in labeling |
| Action | 3M issued an URGENT: Voluntary Product Recall to its consignees on 03/20/2024 via email and USPS certified mail. The notice explained the issue and requested the following: Identify all affected lots in inventory (bulk) or built into kits, including kits that have been distributed. Bulk inventory: use Appendix 1 to determine the correct expiration dates to use when building kits. a. If the affected product in inventory is within the correct expiration date for the affected product correct the expiration date on the bulk package label and ensure future kits reflect the correct expiratio |
| Quantity | 3,515,200 rolls |
| Distribution | Worldwide distribution - US Nationwide in the states of TX, NY, NH, AZ, NC, CA, IL, GA, VA, MD, FL, and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.