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Terminated

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 Recall Z-0503-06 · Posted 2006-02-08

Recalling FirmTeleflex Medical
Recall StatusTerminated
Product CodeBTT
Date Initiated2005-12-01
Date Terminated2006-05-11
Product Quantity1050 units

Reason for Recall

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

Firm Action

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.

Root Cause

Other

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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