Recall Z-0794-2013— Allergen Medical
Class II · Terminated
Class II FDA medical device recall by Allergen Medical, initiated 2013-01-08, terminated 2013-07-29. It names one FDA 510(k) clearance: K080442. Product: SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use in open or laparoscopic procedures.. Reason: Product is dual packaged in an inner and outer pouch, the outer pouch seal may be compromised and sterility may not be assured.
- Recalling firm
- Allergen Medical
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-01-08
- Terminated
- 2013-07-29
- Firm location
- Medford, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.