FDA Medical Device Recalls (openFDA)
Teleflex Medical: Aquapak 640 SW, 650 mL w/040 Adaptor, French, Teleflex Medical, respiratory gas humidifier adaptor.
- Recall number
- Z-2013-2014
- Recalling firm
- Teleflex Medical
- Product
- Aquapak 640 SW, 650 mL w/040 Adaptor, French, Teleflex Medical, respiratory gas humidifier adaptor.
- Status
- Terminated
- Initiated
- 2014-06-05
- Posted
- 2014-07-07
- Terminated
- 2015-07-02
- Reason
- The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.
- Root cause
- Packaging change control
- Action
- Consignees were notified by letter on 06/06/2014.
- Quantity
- 7,758,650 ea. (total for all types listed)
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, Philippines, Singapore, Thailand and Zambia.
- Lot, serial or model codes
- Product Code: 006-40F, Lot numbers: 020126, 046126, 062126, 064126, 080126, 092126, 107126, 108126 & 115126.
- 510(k) numbers
- ["K833974"]
- PMA numbers
- not on file
- Product code
- BTT
- Firm FEI
- 3005747797
- Firm city
- Durham
- Firm state
- NC
- 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