APSOF-7-4-RB, ZIMMON PANCREATIC STENT W/RADIOPAQUE BANDS, Stent Diameter: 7 FR., Length (Between Curl and Flap): 4 CM, F
FDA device recall Z-0080-04 · posted 2003-10-31 · Terminated
Recall details
- Recalling firm
- Wilson-Cook Medical Inc
- Reason for recall
- The label is missing the Rx Only symbol.
- Action taken
- The consignee was notified by the sales representative on/about July 29, 2003 via hand delivered letter. The consignee was informed of the recall and was advised to quarantine and return the affected product, via the Territory Manager. The consignee was urged to complete and return the response portion of the letter.
- Root cause
- Other
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 3 units
- Distribution
- Product was distributed to one account in IL.
- Date initiated
- 2003-07-25
- Date posted
- 2003-10-31
- Date terminated
- 2003-12-04
- Location
- Winston-Salem, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.