Recall Z-2423-2018 ยท FRO Dressing, Wound, Drug
Anika Therapeutics, Inc.
Hyalomatrix, Product nos. 651105, 651103, 651104, and 651301 Product Usage: Hyalomatrix is a bi-layered, sterile, flexible, and comfortable wound dressing that acts as an advanced wound care device. It is comprised of a non-woven pad entirely composed of HY AFF 11, a benzyl ester of hyaluronic acid, and a semipermeable silicone membrane, which controls water vapor loss, provides a flexible coveri
| Date | May 10, 2018 |
| Status | Terminated |
| Reason | Hyalomatrix products are susceptible to degradation as a result of the decomposition of PVC in the packaging material during sterilization, which resulted in degradation of the film. Over the long term it is possible that product integrity may be compromised. |
| Root cause | Package design/selection |
| Action | On May 10, 2018, the firm notified its affected distributor via emailed memorandum of its voluntary recall. The distributor was informed of the affected lots and quantities, and asked to discontinue distribution and sales activities related the affected products. |
| Quantity | 1711 |
| Distribution | US Nationwide Distribution in the state of IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073251 | HYALOMATRIX PA Fidia Advanced Biopolymers Srl, Dec 14, 2007 |