CLASS II Device recall · Reported 16 Jul 2014 · FDA Enforcement Report

Aquapak 640 SW w/040 Adaptor, French, Teleflex Medical recalled

Teleflex Medical is recalling Aquapak 640 SW w/040 Adaptor, French, Teleflex Medical, respiratory gas humidifier adaptor, distributed nationwide in the US. The recall was initiated on 5 Jun 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Code: 006-40F, Lot numbers: 020126, 046126, 062126, 064126, 080126, 092126, 107126, 108126 & 115126.

Quantity recalled7,758,650 ea. (total for all types listed)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2013-2014
FDA event ID: 68493
Recalling firm: Teleflex Medical, Durham, NC
Classification: Class II
Status: Terminated
Recall initiated: 5 Jun 2014
FDA classified: 7 Jul 2014
Reported: 16 Jul 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: CPAP & Ventilators

Timeline

5 Jun 2014	Recall initiated by company
7 Jul 2014	Classified by FDA	+32 days
16 Jul 2014	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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

Where it was distributed

Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, Philippines, Singapore, Thailand and Zambia.

Nationwide

Questions about this recall

Why was it recalled?

The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

Which lots are affected?

Product Code: 006-40F, Lot numbers: 020126, 046126, 062126, 064126, 080126, 092126, 107126, 108126 & 115126.

Where was it sold?

Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, Philippines, Singapore, Thailand and Zambia.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

14 other products · FDA event 68493

This product is part of a recall event; the main page for the event is Aquapak 640 SW w/040 Adaptor, International recalled by Teleflex Medical.

Reported	Class	Recall	Company	Reason	Where
16 Jul 2014	CLASS II	Aquapak 640 SW w/040 Adaptor, International recalled by Teleflex Medical	Teleflex Medical	Packaging Defects	Nationwide
16 Jul 2014	CLASS II	Humidifier Adaptor, 040 Shelf Pak, French, Teleflex Medical recalled	Teleflex Medical	Packaging Defects	Nationwide
16 Jul 2014	CLASS II	Aquapak 340 SW w/040 Adaptor, Teleflex Medical recalled	Teleflex Medical	Packaging Defects	Nationwide
16 Jul 2014	CLASS II	Aquapak 640 SW w/040 Adaptor, Teleflex Medical recalled	Teleflex Medical	Packaging Defects	Nationwide
16 Jul 2014	CLASS II	Aquapak 101 SW w/040 Adaptor, Japan, Teleflex Medical recalled	Teleflex Medical	Packaging Defects	Nationwide
16 Jul 2014	CLASS II	Aquapak 640 SW w/040 Adaptor, Japan, Teleflex Medical recalled	Teleflex Medical	Packaging Defects	Nationwide
16 Jul 2014	CLASS II	Adaptor, 040 Hum, International, Teleflex Medical recalled	Teleflex Medical	Packaging Defects	Nationwide
16 Jul 2014	CLASS II	Humidifier Adaptor 040, Teleflex Medical recalled	Teleflex Medical	Packaging Defects	Nationwide
16 Jul 2014	CLASS II	Aqua 540 SW, 540 w/040 Adaptor, Teleflex Medical recalled	Teleflex Medical	Packaging Defects	Nationwide
16 Jul 2014	CLASS II	Aquapak 340 SW w/040 Adaptor, International recalled by Teleflex Medical	Teleflex Medical	Packaging Defects	Nationwide
16 Jul 2014	CLASS II	Aquapak 340 SW w/040 Adaptor, Japan, Teleflex Medical recalled	Teleflex Medical	Packaging Defects	Nationwide
16 Jul 2014	CLASS II	Aquapak SW/EAU Sterile w/Adaptor, Teleflex Medical recalled	Teleflex Medical	Packaging Defects	Nationwide
16 Jul 2014	CLASS II	Aquapak SW/EAU, Sterile, w/Adaptor, Teleflex Medical recalled	Teleflex Medical	Packaging Defects	Nationwide
16 Jul 2014	CLASS II	Aquapak 340 SW w/040 Adaptor, French, Teleflex Medical recalled	Teleflex Medical	Packaging Defects	Nationwide

More recalls from Teleflex Medical

All 235

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1 Jun 2022Device	CLASS II	Teleflex Flex tube, Product #20011, sterile recalled by Teleflex Medical	Teleflex Medical	Other	Nationwide
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