Z-1627-2013 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
- 6 units
Product Description
-Scorpion Needle, For Use With Scorpion Suture Passer, (Blue). Ref. AR-13990N Lot 123263 -SureFire Scorpion Needle (purple). Ref. AR-13991N Lot 123263 and 122279 -Suture Passing Wire. Ref. AR-1255-18 Lot 123190 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
123263, 122279, 123190.