Hudson RCI One Way Valve, 22mm E.D. to 22mm O.D., REF 1665, Rx Only, Teleflex Medical, Research Triangle park, NC 27709

FDA device recall Z-0652-2010 · posted 2010-01-15 · Terminated

Recall details

Recalling firm

Telefelx Medical

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

Action taken

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

Root cause

Packaging

Status

Terminated

Product code

BZA

Quantity affected

2450 eaches

Distribution

CA, IL, NE, NJ, TX, VA, WI and Canada.

Date initiated

2009-12-02

Date posted

2010-01-15

Date terminated

2010-08-11

Location

Durham, NC