Recall Z-1379-2008 ยท BYE Attachment, Breathing, Positive End Expiratory Pressure
Smiths Medical ASD, Inc.
Smiths Medical FLO2 Emergency Non-rebreather High Flow O2 System; Positive end expiratory pressure breathing attachment; Reference Number: P60000; Smiths Medical, Rockland, MA 02370.
| Date | Jul 16, 2008 (initiated Mar 4, 2008) |
| Status | Terminated |
| Reason | 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 | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 650 |
| Distribution | Worldwide Distribution including USA states of CA, FL, IN, KS, MN, MO, NC, NH, NY, PA and TN, and country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.