Device product
DeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE EO, distributed by DeRoyal Industries.
Z-1134-2014
Product summary
- Event
- Event 67442
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2504 units
- Official record key
device-enforcement:Z-1134-2014
Official wording
Reason: Three lots of circumcision clamps were manufactured out of specification and as a result may not properly clamp at the surgical site completely.
Code information: lot numbers 33347799, 33444071, and 33423747
Distribution pattern: US Distribution to states of: NJ, AL, TX, WA, IL, OK, VA, FL, OR, and KS.
Derived failure modes
-
Potency or specification failure
out of specification