Smiths Medical Oxy-PEEP High Flow O2 with PEEP; Positive end expiratory pressure breathing attachment; Reference Number:
FDA device recall Z-1380-2008 · posted 2008-07-16 · Terminated
Recall details
- Recalling firm
- Smiths Medical ASD, Inc.
- 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.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- BYE
- Quantity affected
- 196
- Distribution
- Worldwide Distribution including USA states of CA, FL, IN, KS, MN, MO, NC, NH, NY, PA and TN, and country of Canada.
- Date initiated
- 2008-03-04
- Date posted
- 2008-07-16
- Date terminated
- 2012-08-20
- Location
- Rockland, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LDS PEEP VALVE (K854822) | Life Design Systems, Inc. | 1986-02-24 |