Recall Z-0259-2008 ยท DQY Catheter, Percutaneous
Boston Scientific Target
Boston Scientific 6F Guider Softip XF Guiding Catheter, 6 French, 40 degree angle, 90cm usable length, Material Number (UPN) H965100420, Catalog Number : 10042, Made in USA: 5905 Nathan Lane, Plymouth, MN 55442 USA
| Date | Nov 24, 2007 (initiated Jul 11, 2007) |
| Status | Terminated |
| Reason | Mislabeling: Catheters were found to be mislabeled (90 cm labeled devices actually contains 100 cm length catheter) |
| Root cause | Labeling mix-ups |
| Action | Firm notified consignees by Urgent Medical Device Recall Letter dated 11 Jul 07 requesting return of product. |
| Quantity | 47 units |
| Distribution | Worldwide Distribution-USA, EU, Japan, South Korea, Mexico, Colombia, and Hungary. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980453 | SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS Boston Scientific Scimed, Inc., Aug 11, 1998 |