Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-2004-2014

June 05, 2014

Class II

Product summary

Firm
Teleflex Medical
Event
Event 68493
Status
Terminated
Classification
Class II
Quantity
7,758,650 ea. (total for all types listed)
Official record key
device-enforcement:Z-2004-2014

Official wording

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

Code information: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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