Medi-Tech Magic Torque Glidex hydrophilic coated guidewire, .035 inch/180 cm and .035 inch/260 cm lengths. Packaged in a
FDA device recall Z-0666-03 · posted 2003-03-20 · Terminated
Recall details
- Recalling firm
- Symbiosis Corp.
- Reason for recall
- The 180 cm guidewire is mislabeled as 260 cm and the 260 cm guidewire is mislabeled as 180 cm.
- Action taken
- A Recall Notification Letter was send to hospitals via Federal Express Overnight Delivery, on 11/27/2002 to the attention of the Risk Manager and the Cath Lab Manager. In addition a response form was included. Recalled units are to be returned to the Boston Scientific Distribution Center located at 500 Commander Shea Blvd., Quincy, MA 02171.
- Root cause
- Other
- Status
- Terminated
- Product code
- DQX
- Quantity affected
- 286
- Distribution
- Product was distributed to 118 hospitals nationwide.
- Date initiated
- 2002-11-27
- Date posted
- 2003-03-20
- Date terminated
- 2012-07-13
- 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 |
|---|---|---|
| MAGIC TORQUE GUIDEWIRE (K933334) | Boston Scientific Corp | 1994-01-26 |