Recall Z-1137-2022 ยท KGN Wound Dressing With Animal-Derived Material(S)
ProgenaCare
progenamatrix Human Keratin Matrix, sterile, Rx, with the following model numbers: (1) PM2012, 12 x 2 cm; (2) PM3002, 2 x 2 cm; (3) PM3004, 4 x 4 cm; PM3006, 6 x 6 cm; and PM3010, 10 x 10 cm.
| Date | Apr 18, 2022 |
| Status | Terminated |
| Reason | Inner pouch seal may be inadequate resulting in lack of sterility. |
| Root cause | Employee error |
| Action | The recalling firm issued letters dated 4/18/2022 via FedEx on 4/18/2022 for all but one consignee, who was hand-delivered the letter on 4/20/2022. The letter identified the product and requested the consignee immediately check their inventory for the affected product and quarantine it prior to return. The consignee is requested to forward the recall notification to any customers who were distributed the product and request it be returned. The consignee was requested to contact the recalling firm by email no later than 4/30/2022 to confirm receipt of the letter and to obtain a Return Mat |
| Quantity | 547 packages |
| Distribution | US Nationwide distribution in the states of AL, GA, FL, TN, and TX. There was no foreign/military/government distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K182010 | ProgenaMatrix Cell Constructs I, LLC, Jan 17, 2019 |