Z-1640-2013 Class II Terminated
FDA device recall Z-1640-2013 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: 34.
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
- 34
Product Description
- ACCU-PASS Suture Shuttle, 70 Degree, Upbend, (Orange) Ref. 72200419 Lot 122504 - Carpal Tunnel Release Blade Assembly, (White) Ref. 81010 Lot 123263, 122406, 122482, 123043, 122518, 122511 - ENDO-SCRUB 2, (1) Sheath, 0 Degree, For K. Storz, Medtronic Sharpsite AC, (Green) 4.0mm Ref. 19-12000 Lot 122289 - Spectrum II Disposable Suture Hook 45 degree, Right (RED) Ref. C6380 Lot 122592 Orthopedic manual surgical instrument.
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, 122504, 122406, 122592, 122482, 123043, 122289, 122518, 122511.