FDA Medical Device Recalls (openFDA)
Teleflex Medical: Aquapak 340 SW, 340, mL w/040 Adaptor, French, Teleflex Medical, respiratory gas humidifier adaptor.
- Recall number
- Z-2008-2014
- Recalling firm
- Teleflex Medical
- Product
- Aquapak 340 SW, 340, 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: 003-40F, Lot numbers: 046127, 049127, 052127, 053127, 055127, 056127, 058127, 059127, 061127, 062127, 065127, 066127, 068127, 069127, 071127, 072127, 074127, 211127, 213127, 215127, 217127, 233127, 236127, 238127, 244127, 247127, 249127, 251127, 253127, 257127, 260127, 261127, 264127, 267127, 270127, 272127, 274127, 276127, 288127, 300127, 304127, 313127, 315127, 317127, 333127, 334127, 336127, 339127, 341127, 343127, 368127, 371127, 376127, 379127, 382127, 396127, 398127, 401127, 405127, 433127, 435127, 438127, 464127, 466127, 468127, 470127, 471127, 473127, 474127, 485127, 488127, 490127, 492127, 495127, 513127 & 518127.
- 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