Aqua 540 SW, 540 w/040 Adaptor, 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-2010-2014
- 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: 005-40, Lot numbers: 001125, 002125, 003125, 004125, 005125, 006125, 007125, 008125, 009125, 010125, 011125, 012125, 013125, 014125, 015125, 016125, 017125, 019125, 020125, 021125, 022125, 023125, 024125, 025125, 026125 & 032125.
Root Cause
Packaging change control
Action Taken
Consignees were notified by letter on 06/06/2014.
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