FDAClass IIJuly 16, 2014

Aquapak SW/EAU recall

Aquapak SW/EAU, Sterile, 340 mL, w/Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.

Why was Aquapak SW/EAU recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Product Code: 003-40C, Lot numbers: 109127, 155127, 157127, 174127, 195127, 222127, 277127, 335127, 337127, 384127, 422127, 425127, 497127 & 500127.

Product
Aquapak SW/EAU, Sterile, 340 mL, w/Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.
Recalling firm
Teleflex Medical
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.
Recall date
July 16, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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