Recall Z-1828-2024 ยท FQM Bandage, Elastic
Andover Healthcare Inc.
Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S)
| Date | May 15, 2024 (initiated Apr 2, 2024) |
| Status | Open, Classified |
| Reason | A packaging seal gap could impact the sterility of the product. |
| Root cause | Process control |
| Action | On April 2, 2024, customers were notified via phone, email and certified mail. Actions to be taken by customer/user: Please identify and return all cases of Batch 0031151359, Lot 10009897233 Sterile CoFlex NL, Tan, 4INx5YD (5400S) made January 2024, shipped February 2024 - March 2024. Please make sure everyone in your organization is fully aware of this corrective action and follows these instructions. 1. Please discontinue the distribution and use of Batch 0031151359, Lot 10009897233, Sterile CoFlex NL Tan 4INx5YD (5400S). 2. Please identify all customers that purchased inventory of Batch 0 |
| Quantity | 108 cases (1,944 individual product packages) |
| Distribution | US Nationwide distribution in the states of CA, CO, GA, IA, IN, OH, MN, NC, PA, TX, VA, WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.