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

FDA device recall Z-0503-06 · posted 2006-02-08 · Terminated

Recall details

Recalling firm

Teleflex Medical

Reason for recall

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

Action taken

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

Status

Terminated

Product code

BTT

Quantity affected

1050 units

Distribution

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

Date initiated

2005-12-01

Date posted

2006-02-08

Date terminated

2006-05-11

Location

Bannockburn, IL