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U.S. Department of Health and Human Services

Class 2 Device Recall Centurion

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  Class 2 Device Recall Centurion see related information
Date Initiated by Firm August 28, 2019
Create Date October 10, 2019
Recall Status1 Terminated 3 on July 23, 2020
Recall Number Z-0121-2020
Recall Event ID 83774
510(K)Number K890897  
Product Classification Clamp, circumcision - Product Code HFX
Product Centurion CIRCLAMP W/1.3 CM BELL-single-use, disposable instrument used to compress the foreskin of the penis during circumcision of a male infant.
ReOrder: 330CR
Code Information Batch/Lot: 2019061201 
Recalling Firm/
Manufacturer		 Centurion Medical Products Corporation
100 Centurion Way
Williamston MI 48895-9086
For Additional Information Contact Lisa A. Carpenter
517-546-5400 Ext. 1156
Manufacturer Reason
for Recall		 A mismatch between the angle of the hole in the base and the angle of the bell, which may cause the clamp to remove foreskin without the use of a scalpel.
FDA Determined
Cause 2		 Process control
Action Centurion Medical Products issued Notification via Certified Mail, Return Receipt on 8/28/19 to customers who received affected product. Letter states reason for recall, helath risk and action to take: identify inventory within your possession and cease use immediately. Complete the enclosed accountability record, whether or not you have product, and fax or email at your earliest convenience to the attention of Lisa Carpenter as directed. Upon receipt of your response Centurion Representative will contact you regarding retrieval of the product from your facility, if required. Forward this recall information to any facilities to whom this product may have been further distributed, instructing them to cease use immediately. Questions: Kara A. Kowalczy Director of Quality Assurance(517) 546-5400 Ext.1122. Centurion mailed four (4) additional customer letters on 9/27 /2019 via Certified Mail, Return Receipt.
Quantity in Commerce 204 each
Distribution Nationwide
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.
510(K) Database 510(K)s with Product Code = HFX and Original Applicant = TRI-STATE HOSPITAL SUPPLY CORP.
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