Allergen Medical Recalls SeriScaffold Surgical Scaffold Due to Sterility Concerns
Allergen Medical is recalling SeriScaffold Surgical Scaffold units because the outer packaging seal may be compromised, potentially compromising sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a potential loss of sterility in a surgical device, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Allergen Medical is recalling specific units of the SeriScaffold Surgical Scaffold, a surgical mesh used in open or laparoscopic procedures. The recall involves 225 units distributed in the United States and 81 units distributed outside the US.
The recall was initiated because the product is dual packaged in an inner and outer pouch, and the outer pouch seal may be compromised. This defect means that sterility may not be assured for the affected devices.
The affected lot numbers are P2012040901 for the US and P2011080101B and P2011090901A for outside the US. Distribution includes the US states of CA, FL, GA, MI, MN, NJ, NY, OH, OR, RI, TX, VA, and WA, as well as Germany, Spain, and the UK. Healthcare providers should check their inventory for these specific lot numbers and stop using the affected devices.
The recalled product
- Product
- SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use in open or laparoscopic procedures.
- Manufacturer
- Allergen Medical
- Category
- Medical Device — Surgical Mesh
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Numbers: P2012040901 (US) P2011080101B and P2011090901A (Outside the US)
Distribution
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