Recall Z-1380-2008
Smiths Medical ASD, Inc. · initiated March 4, 2008
Product
Smiths Medical Oxy-PEEP High Flow O2 with PEEP; Positive end expiratory pressure breathing attachment; Reference Number: P63000; Smiths Medical, Rockland, MA 02370.
Codes / lots: Lot Numbers: 38A30D064 and 38B09D021
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.
FDA-determined 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.
Details
- Recall number
- Z-1380-2008
- Initiated
- March 4, 2008
- Posted by FDA
- July 16, 2008
- Terminated
- August 20, 2012
- Product code
- BYE – Attachment, Breathing, Positive End Expiratory Pressure
- Quantity
- 196
- Distribution
- Worldwide Distribution including USA states of CA, FL, IN, KS, MN, MO, NC, NH, NY, PA and TN, and country of Canada.
- Recalling firm
- Smiths Medical ASD, Inc., Rockland, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1379-2008 | Smiths Medical FLO2 Emergency Non-rebreather High Flow O2 System; Positive end…Incorrect Oxygen Level: Device may not provide expected oxygen concentration or the expected flow rate due… | 03/04/2008Terminated |