Z-0652-2010

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

Name: Z-0652-2010 Hudson RCI One Way Valve, 22mm E.D. to 22mm O.D., REF 1665, Rx Only, Teleflex Medical, Research Triangle...
Creator: Telefelx Medical
Published: 2009-12-02
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2009-12-02 / Terminated / root cause: packaging

FDA source

Telefelx Medical began a recall of Hudson RCI One Way Valve, 22mm E.D. to 22mm O.D., REF 1665, Rx Only, Teleflex Medical, Research Triangle park, NC 27709 on 2009-12-02. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0652-2010
Status: Terminated
Initiated: 2009-12-02
Posted: 2010-01-15
Terminated: 2010-08-11
Recalling firm: Teleflex Medical
Product: Hudson RCI One Way Valve, 22mm E.D. to 22mm O.D., REF 1665, Rx Only, Teleflex Medical, Research Triangle park, NC 27709
Product code: BZA Connector, Airway (Extension)
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
Root cause tag: packaging
FDA root cause: 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.
Product codes and lots: Catalog number: 1665, Lot number: 02J0901967

Product code BZA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)