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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 October 23, 2014
Date Posted January 08, 2015
Recall Status1 Terminated 3 on June 08, 2015
Recall Number Z-0945-2015
Recall Event ID 70081
Product Classification Cardiovascular surgical instruments tray (kit) - Product Code OFA
Product Pacemaker Tray (Cardiovascular Surgical Instruments convenience kit)
Code Information CMP Kit code: OR1955 Lot numbers: 2014061850 Expiration date: 2016-03  
Recalling Firm/
Centurion Medical Products Corporation
100 Centurion Way
Williamston MI 48895-9086
Manufacturer Reason
for Recall
According to the recall notice received from Hospira, the recall was initiated due to a confirmed customer report of particulate in a single unit. Hospira identified the particulate as human hair, embedded in and attached to a pinched area of the stopper.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Centurion sent an Urgent Product Recall Notice dated October 23, 2014, to al affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to identify and remove all affected inventory that may be in their possession and to forward a copy of thie noctice to any cusotmers to whom the affected product may have been further distributed. Customers were asked to complete the enclosed accountability record whether not they have the product and fax to 517-546-3356. Customers with questions were instructed to call 517-546-5400 Ext. 1135. For questions regarding this recall call 517-546-5400, ext 1135.
Quantity in Commerce 8 kits
Distribution Nationwide Distribution including MA, IN, NY, GA, AL, PA, and RI.
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.