Reported Feb 13, 2013 · Terminated
SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use in open or laparoscopic procedures.
Allergen Medical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Allergen Medical · 200 Boston Avenue · Medford, MA · 02155
Is this the product you have?
- SeriScaffold
- Surgical Scaffold Product NumberSCF10X25AGEN. Surgical mesh for use in open or laparoscopic procedures
- Lot codes and dates
- Lot NumbersP2012040901 (US) P2011080101B and P2011090901A (Outside the US)
- Amount recalled
- 225 units (US) and 81 (Outside US)
Where it was sold
Why it 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
This product could cause temporary or reversible health problems — stop using it.
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