Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall DeRoyal ST. Circumcision Clamp, REF 321622, Size 1.3 cm see related information
Date Initiated by Firm January 16, 2014
Date Posted March 04, 2014
Recall Status1 Terminated 3 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 2		 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.
-
-