Z-1636-2013 Class II Terminated
FDA device recall Z-1636-2013 was initiated by Surgical Instrument Service And Savings, Inc. on May 3, 2013 and is designated Class II. Reason for recall: The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch. The recall status is terminated (terminated July 11, 2013). Affected quantity: 2.
Recall Details
- Product Type
- Devices
- Report Date
- July 10, 2013
- Initiation Date
- May 3, 2013
- Termination Date
- July 11, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2
Product Description
- IDEAL 30 Suture Grasper (Green) 30 Degree Ref. 251721 Lot 122511 - IDEAL 60 Suture Grasper (Pink) 60 Degree Ref. 251723 Lot 122631 Passer
Reason for Recall
The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
Distribution Pattern
Nationwide Distribution.
Code Information
122511, 122631.