Recall Z-1777-2022 ยท KGN Wound Dressing With Animal-Derived Material(S)
Collagen Matrix Inc
Collagen Dental Wound Dressing - Bovine Dermis Tap, 25mm x 75mm Product was distributed under the following brand names: 1) Cytoplast RTMTAPE, 25mm x 75mm 2) GIBSON Healthcare, 25mm x 75mm 3) MaxxTape, 2.5cm x 7.5cm x 0.1cm 4) NEOTAPE, 25mm x 75mm 5) Karl Schumacher TAPE, 2.5cm x 7.5cm x 1mm
| Date | Sep 23, 2022 (initiated Aug 3, 2022) |
| Status | Open, Classified |
| Reason | The packaging may not be sealed, which could compromise sterility. |
| Root cause | Packaging change control |
| Action | On August 3, 2022, Collagen Matrix began informing the distributors (initial consignees) to place the lot in question on ship hold. On August 8, 2022, Collagen Matrix began informing distributors by email to return the concerned products. Consignees are asked to return any recalled product to the recalling firm and complete the Certificate of Acknowledgement within 15 days of receipt and return it via email. |
| Quantity | 1336 units |
| Distribution | US distribution to distributors in IL, IN, MI, NC, OH, and TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152600 | Collagen Dental Wound Dressings Collagen Matrix, Inc., Jun 23, 2016 |