Recall record at a glance
| Official record | Z-0794-2013 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Allergen Medical |
| Report date | Feb 13, 2013 |
| Recall initiation date | Jan 8, 2013 |
| Quantity | 225 units (US) and 81 (Outside US) |
| Location | Medford, MA, United States |
Official product description
SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use in open or laparoscopic procedures.
Why the product was recalled
Product is dual packaged in an inner and outer pouch, the outer pouch seal may be compromised and sterility may not be assured
Distribution information
Worldwide Distribution-USA including the states of CA, FL, GA, MI, MN, NJ, NY, OH, OR, RI, TX, VA, and WA, and the countries of Germany, Spain, and UK.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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