FDA Medical Device Recalls (openFDA)
Teleflex Medical: 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
- Recall number
- Z-0503-06
- 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
- Status
- Terminated
- Initiated
- 2005-12-01
- Posted
- 2006-02-08
- Terminated
- 2006-05-11
- Reason
- Teleflex Medical determined that the distribution center shipped unreleased product which did not pass validated sterility test requirements.
- 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
- 1050 units
- Distribution
- Colorado, Nebraska, Oregon, Minnesota, California, Pennsylvania, Michigan, Louisiana, Oklahoma and Texas.
- Lot, serial or model codes
- catalog number 037-00, lot 150150, exp. 2009-10
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BTT
- Firm FEI
- 3004959265
- Firm city
- Bannockburn
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28