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U.S. Department of Health and Human Services

Class 1 Device Recall Dressing Change Tray for CVC & PICC Lines

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  Class 1 Device Recall Dressing Change Tray for CVC & PICC Lines see related information
Date Initiated by Firm January 14, 2011
Date Posted March 08, 2011
Recall Status1 Terminated 3 on June 21, 2011
Recall Number Z-1462-2011
Recall Event ID 57767
Product Classification Kit, wound dressing - Product Code MCY
Product Dressing Change Tray for CVC & PICC Lines, DT12105, Sterile, Centurion Medical Products Corp., Williamston, MI.

These kits are used for dressing changes.
Code Information 2010032290, 2010042690, 2010060790, 2010081690, 2010112990, 2010110890, 2010101190, 2010031590.
Recalling Firm/
Manufacturer		 Centurion Medical Products Corporation
100 Centurion Way
Williamston MI 48895-9086
Manufacturer Reason
for Recall		 The firm is conducting a subrecall of kits containing Triad Groups alcohol prep pads. Triad initiated a recall of prep pads due to a concern about potential contamination of the products with an objectional orgainism, Bacillus cereus.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The firm, Centurion Medical Products, sent an "URGENT PRODUCT RECALL NOTICE" dated January 12, 2011 to affected customers via Certified Mail, Return Receipt Requested. The notice described the product, problem and action to be taken. The customers were instructed to identify and remove all inventory of the recalled kits in their possession; forward a copy of this notice to any customers that this product was further distributed to, and complete and return the attached Accountability Record form via fax to 517-546-3356 or email to: lcarpenter@centurionmp.com. The notice states that a Centurion representative will contact them regarding retrieval of the product from the facility. Should your require additional information, please contact the Director of Quality Assurance & Regulatory Affairs at (517) 546-5400 ext. 1135.
Quantity in Commerce 68056 all kits
Distribution Nationwide distribution: USA including state of: CT, ID, NM, MA, MO, MT, VA and SC.
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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