Recall Z-0666-03 ยท DQX Wire, Guide, Catheter
Symbiosis Corp.
Medi-Tech Magic Torque Glidex hydrophilic coated guidewire, .035 inch/180 cm and .035 inch/260 cm lengths. Packaged in a sterile pouch and a three pack shelf box.
| Date | Mar 20, 2003 (initiated Nov 27, 2002) |
| Status | Terminated |
| Reason | The 180 cm guidewire is mislabeled as 260 cm and the 260 cm guidewire is mislabeled as 180 cm. |
| Root cause | Other |
| Action | 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. |
| Quantity | 286 |
| Distribution | Product was distributed to 118 hospitals nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K933334 | MAGIC TORQUE GUIDEWIRE Boston Scientific Corp, Jan 26, 1994 |