Aquapak 640 SW, 650, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas humidifier adaptor .
This recall has been terminated (originally issued July 7, 2014).
- Company
- Teleflex Medical
- Recall Initiated
- June 5, 2014
- Posted
- July 7, 2014
- Terminated
- July 2, 2015
- Recall Number
- Z-2004-2014
- Quantity
- 7,758,650 ea. (total for all types listed)
- Firm Location
- Durham, NC
- Official Source
- View on FDA website ↗
Reason for Recall
The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, Philippines, Singapore, Thailand and Zambia.
Lot / Code Info
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.
Root Cause
Packaging change control
Action Taken
Consignees were notified by letter on 06/06/2014.