Device product
SYMMETRY SURGICAL DISPOSABLE TOWEL CLAMP, REF 19-4137, STERILE EO, Rx only. Apply clamps parallel to the skin with the angled jaws forming a "V" shape between clamp and drape.
Z-2316-2015
Product summary
- Event
- Event 71300
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,708 units
- Official record key
device-enforcement:Z-2316-2015
Official wording
Reason: Lack of sterility assurance.
Code information: 149053, 149129, 149143, 149604, 149605, 149606, 149682, 149692, 149837, 149853, 154454, 154455, 154456, 154457, 185696, 228161, 229609, 230233, 259154, 259156, 259160, 268906, 268910, and 271548.
Distribution pattern: Worldwide Distribution -- US, including the states of CA, VA, TX, FL, OH, NY, MS, KY, UT, GA, PA, MO, IN, NV, AL, MI, MA, and LA; and, the countries of Germany and Mexico.
Derived failure modes
-
Sterility assurance
Lack of sterility