Recalls / —
—#128059
Product
Aquapak 101 SW, 190, mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier adaptor
- FDA product code
- BTT — Humidifier, Respiratory Gas, (Direct Patient Interface)
- Device class
- Class 2
- Medical specialty
- Anesthesiology
- 510(k) numbers
- K833974
- Affected lot / code info
- Product Code: 001-40J, Lot numbers: 001129 & 002129.
Why it was recalled
The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.
Root cause (FDA determination)
Packaging change control
Action the firm took
Consignees were notified by letter on 06/06/2014.
Recalling firm
- Firm
- Teleflex Medical
- Address
- 4024 Stirrup Creek Dr, Durham, North Carolina 27703-9000
Distribution
- 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.
Timeline
- Recall initiated
- 2014-06-05
- Posted by FDA
- 2014-07-07
- Terminated
- 2015-07-02
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #128059. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.