Z-1634-2013 Class II Terminated
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
Large Tear Cross Cut Rasp 14mm x 7mm Ref. 5100-37-114 Lot 122347 Manual surgical instrument for general use
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
122347