—#125456

Product

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

FDA product code: HFX — Clamp, Circumcision
Device class: Class 2
Medical specialty: Obstetrics/Gynecology
Affected lot / code info: lot numbers 33347799, 33444071, and 33423747

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: DeRoyal Industries Inc
Address: 200 Debusk Ln, Powell, Tennessee 37849-4703

Distribution

Distribution pattern: US Distribution to states of: NJ, AL, TX, WA, IL, OK, VA, FL, OR, and KS.

Timeline

Recall initiated: 2014-01-16
Posted by FDA: 2014-03-04
Terminated: 2015-10-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #125456. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.