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Class 2 Device Recall Hudson RCI One Way Valve |
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Date Initiated by Firm |
December 02, 2009 |
Date Posted |
January 15, 2010 |
Recall Status1 |
Terminated 3 on August 11, 2010 |
Recall Number |
Z-0652-2010 |
Recall Event ID |
53960 |
Product Classification |
Airway connector (Extension) - Product Code BZA
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Product |
Hudson RCI One Way Valve, 22mm E.D. to 22mm O.D., REF 1665, Rx Only, Teleflex Medical, Research Triangle park, NC 27709 |
Code Information |
Catalog number: 1665, Lot number: 02J0901967 |
Recalling Firm/ Manufacturer |
Telefelx Medical 2917 Weck Drive Durham NC 27709
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For Additional Information Contact |
Michael Taggart 919-433-4816
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Manufacturer Reason for Recall |
Products 1664 and 1665 are each one-way valves that offer low flow resistance, each in one, opposite direction. Each of these valves demonstrate the appropriate direction with a red arrow.
The reason for this recall is incorrect packaging; product code 1664 was incorrectly packaged as product code 1665.
If the red arrows are not followed, the valve may be placed in the circuit in the wrong
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FDA Determined Cause 2 |
Packaging |
Action |
Consignees were notified by letter via next day delivery. Each consignee was sent a letter requesting acknowledgement of the recall and a request to return all of the affected product. Each consignee that is a distributor was instructed to forward the letter to their consignees to retrieve relevant product from those locations. A second mailing to non-responding customers on the consignee list will be made approximately four to six weeks after the first mailing. A third mailing to non-responding customers on the consignee list will be made approximately four to six weeks after the second mailing or as an alternative, they may be contacted by phone, e-mail, or fax. A record of these contacts will be maintained. Affected products received by Teleflex will be destroyed or reworked and replacement product or credit will be provided to the consignees. Records of destruction or rework will be maintained.
Questions are directed to the firm's sales representatives or to Teleflex Customer Service at 1-866-246-6990 |
Quantity in Commerce |
2450 eaches |
Distribution |
CA, IL, NE, NJ, TX, VA, WI and Canada. |
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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