Z-1108-2015Class II

Aquapak 340 Sw, 340Ml W/040 Adaptor, Intl

Name: Z-1108-2015 Aquapak 340 Sw, 340Ml W/040 Adaptor, Intl
Creator: Teleflex Medical
Published: 2015-01-14
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2015-01-14 / Terminated / root cause: manufacturing process

FDA source

Teleflex Medical began a recall of AQUAPAK 340 SW, 340ML W/040 ADAPTOR, INTL. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to... on 2015-01-14. FDA classified it as Class II and gives the reason as "The packages may contain foreign material (black particles)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1108-2015
Classification: Class II
Status: Terminated
Initiated: 2015-01-14
Posted: 2015-02-12
Terminated: 2017-12-04
Recalling firm: Teleflex Medical
Product: AQUAPAK 340 SW, 340ML W/040 ADAPTOR, INTL. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.
Product code: BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Reason for recall: The packages may contain foreign material (black particles).
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Teleflex sent and Urgent Medical Device Recall Notification letter dated January 14, 2015 to all affected customers. The letter identified the affect product, problem and actions to be taken. Customers were instructed to immediately discontinue use and quarantine any products with the affected catalog numbers and lot numbers. Customers were asked to complete and return the enclosed Recall Acknowledgement Form. For questions contact your local sales representative or Customer Service at 1-866-246-6990.
Quantity in commerce: 15,779,607 units
Distribution: Worldwide Distribution - U.S. Nationwide and the countries of: Australia, Bahrain, Belgium, Bermuda, Brazil, Canada, China, Ecuador, Germany, Great Britain, Hong Kong, Indonesia, Japan, Jordan, Malaysia, Mexico, New Zealand, Philippines, Singapore, South Korea, Saudi Arabia, Taiwan, Thailand, Uruguay and Zambia.
Product codes and lots: Product Code: 400340, Lot numbers: 001147, 061137, 313147, 059137, 010147, 293137, 038147, 225137, 558137, 362137, 202147, 425137, 301147, 263137, 366137, 076147, 316137, 424137, 012147, 155137, 147137, 597137, 478137, 235147, 278147, 228147, 013147, 303137, 523137, 023147, 206147, 336137, 279147, 481137, 618137, 179137, 025147, 248137, 086147, 252147, 392137, 533137, 551137, 191137, 563137, 270137, 042147, 502137, 080137, 299147, 207137, 022147, 516137, 165137, 387137, 104147, 645137, 220137, 494137, 578137, 385137, 305147, 183137, 390137, 650137, 383137, 041147, 186137, 299137, 246137, 389137, 531137, 027147, 006147, 266137, 236137, 297147, 116147, 189137, 491137, 008147, 208137, 191147, 057137, 480137, 229137, 309137, 611137, 107137, 313137, 163137, 568137, 420137, 474137, 231147, 281147, 234137, 100147, 216137, 300137, 472137, 328137, 485137, 159137, 203147, 353137, 590137, 082147, 556137, 614137, 161137, 469137, 488137, 035147, 194147, 223137, 641137, 489137, 475137, 197147, 024147, 044147, 200147, 203137, 509137, 477137, 213137, 205147, 030147, 594137, 349137, 580137, 190147, 416137, 256147, 033147, 262147, 471137, 413137, 338137, 103137, 149137, 410137, 297137, 346137, 426137, 200137, 569137, 287137, 463137, 575137, 102147, 470137, 582137, 286137, 032147, 307137, 193147, 104137, 290137, 101147, 467137, 572137, 261137, 036147, 197137, 282147, 647137, 103147, 527137, 554137, 331137, 512137, 259137, 505137, 560137, 047147, 125147, 156137, 128147, 305137, 343137, 196147, 465137, 476137, 284147, 391137, 189147, 524137, 078147, 039147, 483137, 334137, 145137, 479137, 549137, 365137, 072147, 253147, 026147, 545137, 283147, 132147, 153137, 407137, 151137, 243137, 136147, 029147, 186147, 227137, 518137, 122147, 356137, 259147, 114147, 194137 & 182137.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1108-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1095-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-18	2015-02-11
Z-1096-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-18	2015-02-11
Z-1097-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-18	2015-02-11
Z-1098-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-18	2015-02-11
Z-1099-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-18	2015-02-11
Z-1100-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-18	2015-02-11
Z-1101-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-18	2015-02-11
Z-1102-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-18	2015-02-11
Z-1103-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-18	2015-02-11
Z-1104-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-18	2015-02-11
Z-1105-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-18	2015-02-11
Z-1106-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-18	2015-02-11
Z-1107-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-18	2015-02-11
Z-1108-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-18	2015-02-11
Z-1109-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-18	2015-02-11

Product code BTT

K833974Class IIAquapak 020 Humidifier AdapterRespiratory Care, Inc. / cleared 1983-12-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)