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U.S. Department of Health and Human Services

Class 2 Device Recall Hudson RCI One Way Valve

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  Class 2 Device Recall Hudson RCI One Way Valve see related information
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
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
For Additional Information Contact Michael Taggart
919-433-4816
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
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
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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