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Terminated

Humidifier Adaptor, 040 Shelf Pak, French, Teleflex Medical, respiratory gas humidifier adaptor.

FDA Recall Z-2017-2014 · Posted 2014-07-07

Recalling FirmTeleflex Medical
Recall StatusTerminated
Product CodeBTT
Date Initiated2014-06-05
Date Terminated2015-07-02
Product Quantity7,758,650 ea. (total for all types listed)

Reason for Recall

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

Firm Action

Consignees were notified by letter on 06/06/2014.

Root Cause

Packaging change control

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K833974AQUAPAK 020 HUMIDIFIER ADAPTERRespiratory Care, Inc. · 1983-12-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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