FDA Medical Device Recalls (openFDA)
Teleflex Medical: Aquapak 340 SW, 340, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas humidifier adaptor .
- Recall number
- Z-2003-2014
- Recalling firm
- Teleflex Medical
- Product
- Aquapak 340 SW, 340, mL w/040 Adaptor, International, 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 respiratory gas humidifier 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: 400340, Lot numbers: 082127, 085127, 088127, 092127, 094127, 097127, 100127, 102127, 104127, 106127, 108127, 137127, 141127, 145127, 148127, 154127, 156127, 159127, 161127, 163127, 194127, 198127, 200127, 204127, 207127, 209127, 223127, 224127, 226127, 228127, 230127, 232127, 239127, 241127, 243127, 245127, 246127, 248127, 250127, 252127, 256127, 259127, 263127, 266127, 269127, 289127, 290127, 292127, 307127, 309127, 312127, 314127, 316127, 318127, 320127, 322127, 338127, 340127, 345127, 350127, 353127, 356127, 359127, 386127, 388127, 390127, 392127, 395127, 399127, 403127, 406127, 410127, 414127, 419127, 421127, 430127, 432127, 447127, 450127, 453127, 456127, 459127, 462127, 465127, 467127, 477127, 478127, 481127, 483127, 486127, 487127, 489127, 491127, 493127, 496127, 516127, 577127 & 580127.
- 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