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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 June 02, 2010
Date Posted February 09, 2011
Recall Status1 Terminated 3 on February 09, 2011
Recall Number Z-1086-2011
Recall Event ID 56391
Product Classification PICC line tray - Product Code LRS
Product Centurion Medical Products PICC line tray DT3185, Sterile.
Code Information 2009093050 and 2009101550
Recalling Firm/
Manufacturer		 Centurion Medical Products
301 Catrell Dr
Howell MI 48843-1703
For Additional Information Contact Matthew Price
517-546-5400
Manufacturer Reason
for Recall		 The kits contain heparin lock flush solution USP code 504505 that is under recall by APP Pharmaceuticals. APP Pharmaceuticals is recalling the heparin because of incomplete documentation associated with test results.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Centurion Medical Products sent out Urgent Product Recall Notices on 6/3/2010. A second recall notice was sent to nonresponding consignees on 6/21/2010. The letter instructed the consignees to quarantine the recalled product and contact Centurion so that the recalled product can be retrieved.
Quantity in Commerce 380
Distribution Nationwide distribution.
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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