Smiths Medical FLO2 Emergency Non-rebreather High Flow O2 System; Positive end expiratory pressure breathing attachment; Reference Number: P60000; Smiths Medical, Rockland, MA 02370.
This recall has been terminated (originally issued July 16, 2008).
- Company
- Smiths Medical Asd, Inc.
- Recall Initiated
- March 4, 2008
- Posted
- July 16, 2008
- Terminated
- August 20, 2012
- Recall Number
- Z-1379-2008
- Quantity
- 650
- Firm Location
- Rockland, MA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Worldwide Distribution including USA states of CA, FL, IN, KS, MN, MO, NC, NH, NY, PA and TN, and country of Canada.
Lot / Code Info
Lot Numbers: 37L04D188 and 38A030257
Root Cause
Nonconforming Material/Component
Action Taken
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.