FDA Device

DeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE EO, distributed by DeRoyal Industries.

Hazard

Three lots of circumcision clamps were manufactured out of specification and as a result may not properly clamp at the surgical site completely.

What You Should Do

Remedy

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.

Products

DeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE EO, distributed by DeRoyal Industries.
Brand
DeRoyal Industries Inc
UPC
lot numbers 33347799, 33444071, and 33423747

Units Affected

2504 units