SeriScaffold Surgical Scaffold Product Number recall: Sterility Concern
SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use in open or laparoscopic procedures.
Why was SeriScaffold Surgical Scaffold Product Number recalled?
Product is dual packaged in an inner and outer pouch, the outer pouch seal may be compromised and sterility may not be assured
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: P2012040901 (US) P2011080101B and P2011090901A (Outside the US)
- Product
- SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use in open or laparoscopic procedures.
- Recalling firm
- Allergen Medical
- Quantity
- 225 units (US) and 81 (Outside US)
- Distribution
- 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.
- Recall date
- February 13, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)