| Class 1 Device Recall INPATIENT Port Access Dressing Tray | |
Date Initiated by Firm | January 14, 2011 |
Date Posted | March 08, 2011 |
Recall Status1 |
Terminated 3 on June 21, 2011 |
Recall Number | Z-1469-2011 |
Recall Event ID |
57767 |
Product Classification |
Kit, wound dressing - Product Code MCY
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Product | IN-PATIENT Port Access Dressing Tray, DT14880, Sterile, Centurion Medical Products Corp., Williamston, MI.
These kits are used for dressing changes. |
Code Information |
2010090950, 2010111250, 2010121550, 2010032250, 2010061050, 2010080450, 2010060150, 2010031250. |
Recalling Firm/ Manufacturer |
Centurion Medical Products Corporation 100 Centurion Way Williamston MI 48895-9086
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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 |
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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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