Product is a ChoICE 182 cm Guide Wire, intended to facilitate placement of balloon dilatation catheters and other therap
FDA device recall Z-0592-03 · posted 2003-02-27 · Terminated
Recall details
- Recalling firm
- Symbiosis Corp.
- Reason for recall
- Product is mislabled as a ChoICE Floppy Guide Wire when it is actually a ChoICE ES(Extra Support) Guide Wire.
- Action taken
- Recall Letters issued 11/19/2002 via Federal Express to 7 hospital accounts. Consignees were requested to fill out a response form and return product to their Quincy, MA facility.
- Root cause
- Other
- Status
- Terminated
- Product code
- DQX
- Quantity affected
- 19/5-pack units
- Distribution
- Product was distributed to hospitals in FL, MI, GA, OR, ID AND CT. 05.
- Date initiated
- 2002-11-19
- Date posted
- 2003-02-27
- Date terminated
- 2008-04-15
- Location
- Miami, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SCIMED CHOICE PT VISION PTCA GUIDE WIRE (K962572) | Scimed Life Systems, Inc. | 1996-12-17 |