—#43154

Product

AquaPak Sterile Water for Inhalation, USP, 760 mL blow-molded plastic bottle for use with a respiratory gas humidifier; 10 bottles per case; manufactured by Hudson Respiratory Care, Inc., Temecula, CA 92589-9020 USA; catalog #037-00

FDA product code: BTT — Humidifier, Respiratory Gas, (Direct Patient Interface)
Device class: Class 2
Medical specialty: Anesthesiology
Affected lot / code info: catalog number 037-00, lot 150150, exp. 2009-10

Why it was recalled

Teleflex Medical determined that the distribution center shipped unreleased product which did not pass validated sterility test requirements.

Root cause (FDA determination)

Other

Action the firm took

Teleflex Medical sent recall letters dated 12/1/05 to their direct accounts on the same date via UPS overnight. The accounts were informed that the lot did not pass validated sterility test requirements, and were instructed to cease distribution and use of the lot and quarantine it for return to Teleflex Medical, Durham, NC. The wholesalers were requested to notify their customers of the recall and have them return their inventory of the lot to the direct account for consolidation and return to Teleflex. Questions were directed to Dan Daily at 1-800-334-9751, ext. 4948.

Recalling firm

Firm: Teleflex Medical
Address: 2345 Waukegan Rd, Ste 120, Bannockburn, Illinois 60015-1580

Distribution

Distribution pattern: Colorado, Nebraska, Oregon, Minnesota, California, Pennsylvania, Michigan, Louisiana, Oklahoma and Texas.

Timeline

Recall initiated: 2005-12-01
Posted by FDA: 2006-02-08
Terminated: 2006-05-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #43154. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.