Z-2004-2014Class II

Aquapak 640 SW, 650, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas humidifier adaptor

Name: Z-2004-2014 Aquapak 640 SW, 650, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas humidifier adaptor
Creator: Teleflex Medical
Published: 2014-06-05
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2014-06-05 / Terminated / root cause: packaging

FDA source

Teleflex Medical began a recall of Aquapak 640 SW, 650, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas humidifier adaptor on 2014-06-05. FDA classified it as Class II and gives the reason as "The seals of the adaptor packaging may be creased which may potentially affect packaging integrity". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2004-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-05
Posted: 2014-07-07
Terminated: 2015-07-02
Recalling firm: Teleflex Medical
Product: Aquapak 640 SW, 650, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas humidifier adaptor .
Product code: BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Reason for recall: The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.
Root cause tag: packaging
FDA root cause: Packaging change control
Action: Consignees were notified by letter on 06/06/2014.
Quantity in commerce: 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.
Product codes and lots: Product Code: 400640, Lot numbers: 021126, 022126, 030126, 031126, 032126, 033126, 034126, 037126, 038126, 039126, 040126, 047126, 048126, 049126, 050126, 051126, 052126, 059126, 060126, 061126, 066126, 067126, 072126, 073126, 074126, 081126, 082126, 083126, 084126, 085126, 093126, 094126, 095126, 096126, 100126, 101126, 102126, 103126, 104126, 109126, 110126, 116126, 117126, 118126, 119126, 125126, 126126, 127126 & 151126.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2004-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2003-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-16	2014-07-07
Z-2004-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-16	2014-07-07
Z-2005-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-16	2014-07-07
Z-2006-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-16	2014-07-07
Z-2007-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-16	2014-07-07
Z-2008-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-16	2014-07-07
Z-2009-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-16	2014-07-07
Z-2010-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-16	2014-07-07
Z-2011-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-16	2014-07-07
Z-2012-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-16	2014-07-07
Z-2013-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-16	2014-07-07
Z-2014-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-16	2014-07-07
Z-2015-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-16	2014-07-07
Z-2016-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-16	2014-07-07
Z-2017-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-16	2014-07-07

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)