CLASS II Device recall · Reported 18 Feb 2015 · FDA Enforcement Report

Aquapak 640 Sw W/040 Adaptor recalled by Teleflex Medical

Teleflex Medical is recalling Aquapak 640 Sw W/040 Adaptor, distributed nationwide in the US. The recall was initiated on 14 Jan 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Code: 006-40, Lot numbers: 033136, 030136, 028136, 026136, 042146, 061146, 125136, 061136, 038146, 139136, 024136, 101136, 135136, 173136, 198136, 067136, 192136, 177136, 059136, 022146, 067146, 119136, 034136, 045146, 152136, 157136, 042136, 053136, 051146, 100136, 145136, 045136, 137136, 047136, 182136, 176136, 154136, 172136, 131136, 138136, 191136, 021146, 190136, 098136, 050146, 156136, 185136, 043136, 096136, 189136, 150136, 044136, 155136, 181136, 184136, 043146, 196136, 144136, 136136, 183136, 072136, 188136, 197136, 049146, 099136, 073136, 151136, 041136, 071136, 064146, 065146, 064136, 063136, 066136, 060146, 058136, 065136, 186136, 025136, 097136, 124136, 046136, 044146 & 066146.

Quantity recalled15,779,607 units

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-1103-2015
FDA event ID: 70280
Recalling firm: Teleflex Medical, Research Triangle Park, NC
Classification: Class II
Status: Terminated
Recall initiated: 14 Jan 2015
FDA classified: 11 Feb 2015
Reported: 18 Feb 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Particulate Matter
Device type: Other Medical Devices

Timeline

14 Jan 2015	Recall initiated by company
11 Feb 2015	Classified by FDA	+28 days
18 Feb 2015	Published in enforcement report	+7 days

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

Reason for recall

The packages may contain foreign material (black particles).

Product as listed by the FDA

AQUAPAK 640 SW, 650ML W/040 ADAPTOR. 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.

Where it was distributed

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.

Nationwide

Questions about this recall

Is Aquapak 640 Sw W/040 Adaptor recalled?

Yes. Teleflex Medical recalled Aquapak 640 Sw W/040 Adaptor on 14 Jan 2015. The recall is Class II and its status is Terminated. Recall number Z-1103-2015.

Why was it recalled?

The packages may contain foreign material (black particles).

Which lots are affected?

Product Code: 006-40, Lot numbers: 033136, 030136, 028136, 026136, 042146, 061146, 125136, 061136, 038146, 139136, 024136, 101136, 135136, 173136, 198136, 067136, 192136, 177136, 059136, 022146, 067146, 119136, 034136, 045146, 152136, 157136, 042136, 053136, 051146, 100136, 145136, 045136, 137136, 047136, 182136, 176136, 154136, 172136, 131136, 138136, 191136, 021146, 190136, 098136, 050146, 156136, 185136, 043136, 096136, 189136, 150136, 044136, 155136, 181136, 184136, 043146, 196136, 144136, 136136, 183136, 072136, 188136, 197136, 049146, 099136, 073136, 151136, 041136, 071136, 064146, 065146, 064136, 063136, 066136, 060146, 058136, 065136, 186136, 025136, 097136, 124136, 046136, 044146 & 066146.

Where was it sold?

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

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