DeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE EO, distributed by DeRoyal Industries.
FDA Recall Z-1134-2014 · Posted 2014-03-04
Recalling FirmDeRoyal Industries Inc
Recall StatusTerminated
Product CodeHFX
Date Initiated2014-01-16
Date Terminated2015-10-13
Product Quantity2504 units
Reason for Recall
Three lots of circumcision clamps were manufactured out of specification and as a result may not properly clamp at the surgical site completely.
Firm Action
DeRoyal initiated the recall by sending overnight letters to its direct accounts on 01/16/2014. If distributors inform DeRoyal of further distribution, DeRoyal will contact those consignees in the same manner. If necessary, further communications will be sent in the form of another mailing, phone calls, and emails to materials management personnel when possible.
Root Cause
Process control
Distribution Pattern
US Distribution to states of: NJ, AL, TX, WA, IL, OK, VA, FL, OR, and KS.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.