Drug recall
Hyalomatrix, Product nos. 651105, 651103, 651104, and 651301 Product Usage: Hyalomatrix is a bi-layered…
FDA recall event 80291 · Class II · Anika Therapeutics, Inc.
Key facts
| Event ID | 80291 |
|---|---|
| Recall numbers | Z-2423-2018 |
| Recalling firm | Anika Therapeutics, Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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… |
| Initiation date | May 10, 2018 |
| Report date | Jul 18, 2018 |
| Termination date | May 10, 2019 |
| City | Bedford |
| State | MA |
| Country | United States |
| FEI number | 3007093114 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: