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U.S. Department of Health and Human Services

Class 2 Device Recall Minor Dressing Tray

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  Class 2 Device Recall Minor Dressing Tray see related information
Date Initiated by Firm December 06, 2010
Date Posted February 01, 2011
Recall Status1 Terminated 3 on February 16, 2011
Recall Number Z-1016-2011
Recall Event ID 57661
Product Classification Kit, i.V. Start - Product Code LRS
Product Minor Dressing Tray, Reorder DT14405, Sterile, Centurion Medical Products Corp. Williamston, MI

Intended use: Vascular access port kit
Code Information 2009111880, 2010020880, 2009121680, 2010021680, 2009121580, 2009111780, 2009111680, 2010011880, 2010021580.
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 firm is conducting a recall of kits that contain the MONOJECT PREFILL ADVANCED flush syringes containing heparin. The syringes are under recall by their manufacturer Coviden because of testing that showed "that the crude heparin used to produce a specific batch of purified heparin sodium USP contained low level of Over-Sulfated Chondroitin Sulfate (OSCS)".
FDA Determined
Cause 2		 Other
Action The firm, Covidien, sent an "URGENT PRODUCT RECALL" letter dated November 12, 2010, to affected customers via Certified Mail, Return Receipt Requested. The letter describes the product, problem and action to be taken by the customers. The customers were instructed to examine their inventory and in-use stock to determine if they have any units of the affected product, if found, immediately remove from inventory and quarantine; if they are a distributor they were ask to notify their customers of this letter; and complete and return the PRODUCT RECALL FORM whether or not they have the affected product via fax to: 203-822-6009 or scan and email to: sdfeedback@covidien.com. Note: The returned product will be collected and counted prior to destruction or return to the vendor. Should you have any medical questions concerning this recall, please call 508-261-6393. For Customer Service questions regarding the recall, please use one of the following methods: phone 1-800-962-9888 option 1 (8am to 6:30pm Eastern); email: sdfeedback@covidien.com or fax: 302-822-6009.
Quantity in Commerce 1300 kits
Distribution Nationwide Distribution: USA including states of: OH, WI, IL, MO and TX.
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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