Recalls / —
—#68610
Product
Smiths Medical FLO2 Emergency Non-rebreather High Flow O2 System; Positive end expiratory pressure breathing attachment; Reference Number: P60000; Smiths Medical, Rockland, MA 02370.
- FDA product code
- BYE — Attachment, Breathing, Positive End Expiratory Pressure
- Device class
- Class 2
- Medical specialty
- Anesthesiology
- Affected lot / code info
- Lot Numbers: 37L04D188 and 38A030257
Why it was recalled
Incorrect Oxygen Level: Device may not provide expected oxygen concentration or the expected flow rate due to incorrectly molded part. Patient will not receive proper amounts of air/oxygen when in need.
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
Consignees were notified on 2/26/08 via telephone to place the affected products on hold pending further instruction from the recalling firm. A follow-up letter was issued on 3/4/08 advising consignees to return any product in stock for a replacement or credit. Distributors were requested to provide their customer lists to the recalling firm in order to notify their customers of this recall.
Recalling firm
- Firm
- Smiths Medical ASD, Inc.
- Address
- 160 Weymouth St, Rockland, Massachusetts 02370-1136
Distribution
- Distribution pattern
- Worldwide Distribution including USA states of CA, FL, IN, KS, MN, MO, NC, NH, NY, PA and TN, and country of Canada.
Timeline
- Recall initiated
- 2008-03-04
- Posted by FDA
- 2008-07-16
- Terminated
- 2012-08-20
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #68610. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.