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U.S. Department of Health and Human Services

Class 2 Device Recall Centurion Medical Products

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  Class 2 Device Recall Centurion Medical Products see related information
Date Initiated by Firm October 24, 2019
Create Date November 06, 2019
Recall Status1 Terminated 3 on June 24, 2020
Recall Number Z-0344-2020
Recall Event ID 84165
Product Classification General surgery tray - Product Code LRO
Product Centurion Medical Products UNIVERSAL LINE FULL BODY DRAPE KIT - REG
Code: DT11955
Code Information Lot/Batch Number: 2019052190 Exp Date: 5/31/2024 
Recalling Firm/
Manufacturer		 Centurion Medical Products Corporation
100 Centurion Way
Williamston MI 48895-9086
Manufacturer Reason
for Recall		 Sterile packaging incomplete seals may compromise sterility of the product
FDA Determined
Cause 2		 Process control
Action Centurion medical issued notification was emailed to the affected distributor on October 24, 2019, Centurion's parent company, Med line Industries. Centurion mailed a letter to the single affected medical facility on 10/24/19, via certified mail, return receipt. The letter provides reason for recall, heath risk and action to take: be accessed for use. (1) Identify all inventory that you have within your possession and segregate it in a location where it cannot be accessed for use 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. Questions Contact Director of Quality Assurance, Centurion Medical Products Corporation (517) 546-5400 Ext.1122
Quantity in Commerce 80 units
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.
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