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Recall Observatory FDA recall evidence

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

January 16, 2014

Class II

Product summary

Firm
DeRoyal Industries Inc
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

    reason.potency_specification_failure · v1.0.0

    out of specification