Z-0503-06

AquaPak Sterile Water for Inhalation, USP, 760 mL blow-molded plastic bottle for use with a respiratory gas...

Name: Z-0503-06 AquaPak Sterile Water for Inhalation, USP, 760 mL blow-molded plastic bottle for use with a respiratory gas...
Creator: Teleflex Medical
Published: 2005-12-01
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2005-12-01 / Terminated / root cause: sterility

FDA source

Teleflex Medical began a recall of 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... on 2005-12-01. The reason FDA records is "Teleflex Medical determined that the distribution center shipped unreleased product which did not pass validated sterility test requirements". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0503-06
Status: Terminated
Initiated: 2005-12-01
Posted: 2006-02-08
Terminated: 2006-05-11
Recalling firm: Teleflex Medical
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
Product code: BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Reason for recall: Teleflex Medical determined that the distribution center shipped unreleased product which did not pass validated sterility test requirements.
Root cause tag: sterility
FDA root cause: Other
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.
Quantity in commerce: 1050 units
Distribution: Colorado, Nebraska, Oregon, Minnesota, California, Pennsylvania, Michigan, Louisiana, Oklahoma and Texas.
Product codes and lots: catalog number 037-00, lot 150150, exp. 2009-10

Product code BTT

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)