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U.S. Department of Health and Human Services

Class 2 Device Recall CIRCUMCISION TRAY Kit

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  Class 2 Device Recall CIRCUMCISION TRAY Kit see related information
Date Initiated by Firm July 01, 2019
Create Date August 06, 2019
Recall Status1 Terminated 3 on June 26, 2020
Recall Number Z-2164-2019
Recall Event ID 83329
Product Classification Circumcision tray - Product Code OHG
Product CIRCUMCISION TRAY Kit Code: CIT2650H - Product Usage: Kit is used for performing circumcision procedures on newborns.
Code Information Lot # 2019051390  Exp: 8/31/2021    
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		 Potential for sterile packaging to be compromised
FDA Determined
Cause 2		 Employee error
Action 1) Please identify all inventory that you have within your possession and segregate the recalled product. 2) Please 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 this record, your response will be documented, and a Centurion Representative will contact you regarding retrieval of the product from your facility, if required. 3) Please forward a copy of this notice to any facilities to whom this product may have been further distributed. Please contact the number for any question (517) 546-5400 Ext.1122.
Quantity in Commerce 168 each
Distribution US Nationwide distribution in the states of AZ, CA, FL, GA, IL, KY, MA, MD, MI, NC, NH, NY, OH, SC, TX, TN, VA, WA, WI.
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.
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