Recall Z-0976-2009 ยท MJQ
Spectranetics Corporation
Turbo Elite 0.9mm Turbo Elite (TE) RX, Model #410-154, tip diameter 0.9mm/.038 in, 4 Fr, sterile EO. Manufactured by Spectranetics, 96 Talamine Court, Colorado Springs, CO 80907. The pouch label of the 1.4mm TE Over the Wire (OTW) catheter, Ref # 414-151, L/N# 080417D was incorrectly labeled for size as 0.9mm TE RX, Ref# 410-154, L/N#080417D. The box labels are correct and match the devices in
| Date | Feb 11, 2009 (initiated Jul 4, 2008) |
| Status | Terminated |
| Reason | The catheter pouch label was incorrectly labeled with the wrong size. |
| Root cause | Error in labeling |
| Action | The mislabeled catheter was returned to Spectranetics. The second possible mislabeled catheter was visually inspected by a Spectranetics representative and confirmed the catheter was labeled correctly. |
| Quantity | 2 units |
| Distribution | Nationwide Distribution including states of TX and FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071227 | CLIRPATH TURBO EXCIMER LASER CATHETER (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX) -2.0MM, MODEL 310-154, 314-159, 317-15 Spectranetics Corp., Jul 11, 2007 |