Class 2 Device Recall DeRoyal ST. Circumcision Clamp, REF 321622, Size 1.3 cm

• Date Initiated by Firm: January 16, 2014
• Date Posted: March 04, 2014
• Recall Status: Terminated on October 13, 2015
• Recall Number: Z-1134-2014
• Recall Event ID: 67442
• Product Classification: Clamp, circumcision - Product Code HFX
• Product: DeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE EO, distributed by DeRoyal Industries.
• Code Information: lot numbers 33347799, 33444071, and 33423747
• Recalling Firm/ Manufacturer: DeRoyal Industries Inc; 200 Debusk Ln; Powell TN 37849-4703
• For Additional Information Contact: Mr. Tracy Edmundson; 865-362-2334
• Manufacturer 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.
• FDA Determined Cause: Process control
• 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.
• Quantity in Commerce: 2504 units
• Distribution: US Distribution to states of: NJ, AL, TX, WA, IL, OK, VA, FL, OR, and KS.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.