Drug recall
SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use in open or laparoscopic…
FDA recall event 64069 · Class II · Allergen Medical
Key facts
| Event ID | 64069 |
|---|---|
| Recall numbers | Z-0794-2013 |
| Recalling firm | Allergen Medical |
| Product type | Devices |
| Products | SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use in open or laparoscopic procedures. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Product is dual packaged in an inner and outer pouch, the outer pouch seal may be compromised and sterility may not be assured |
| Initiation date | Jan 8, 2013 |
| Report date | Feb 13, 2013 |
| Termination date | Jul 29, 2013 |
| City | Medford |
| State | MA |
| Country | United States |
| FEI number | 3008374097 |
At a glance
- 1–9 Products in this recall
- 1–9 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: