Z-0794-2013 Class II Terminated
FDA device recall Z-0794-2013 was initiated by Allergen Medical on January 8, 2013 and is designated Class II. 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 The recall status is terminated (terminated July 29, 2013). Affected quantity: 225 units (US) and 81 (Outside US).
Recall Details
- Product Type
- Devices
- Report Date
- February 13, 2013
- Initiation Date
- January 8, 2013
- Termination Date
- July 29, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 225 units (US) and 81 (Outside US)
Product Description
SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use in open or laparoscopic procedures.
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
Distribution Pattern
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.
Code Information
Lot Numbers: P2012040901 (US) P2011080101B and P2011090901A (Outside the US)