Portex Continuous Epidural tray Ref 4948-17
FDA device recall Z-0211-2007 · posted 2006-11-22 · Terminated
Recall details
- Recalling firm
- Smiths Medical ASD, Inc.
- Reason for recall
- Misbranded: Tray label states 26G x 5/8 inch, needle is 25 G x 1 inch
- Action taken
- Smith Medical notified Dealers and direct customers contacted via letter delivered by Federal Express on October 27, 2006. Customers of dealers will be notified upon receipt of the dealer customer list.
- Root cause
- Other
- Status
- Terminated
- Product code
- CAZ
- Quantity affected
- 540 units
- Distribution
- Nationwide and Panama
- Date initiated
- 2006-10-27
- Date posted
- 2006-11-22
- Date terminated
- 2012-05-22
- Location
- Keene, NH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| REGIONAL ANESTHESIA TRAYS (K965017) | Smiths Industries Medical Systems, Inc. | 1997-03-14 |