Recall Z-0698-2008 ยท DQY Catheter, Percutaneous
Spectranetics Corporation
Spectranetics Quick-Cross Support Catheters, .035in x 90cm, REF#: 518-036, Sterile, Manufactured by: Spectranetics, Colorado Springs, Colorado 80907.
| Date | Feb 5, 2008 (initiated Dec 10, 2007) |
| Status | Terminated |
| Reason | Mislabeling: Catheters were placed into mis-labeled inner pouches as REF Number 518-037, 135 cm--the exterior box labeling is correct as 90 cm. |
| Root cause | Packaging process control |
| Action | Consignees were notified by Dear Healthcare provider letter on 12/10/2007 and were told that a sales rep would remove and replace all affected catheters. |
| Quantity | 64 |
| Distribution | Nationwide including states of FL, IL, IN, MO, NC, NY, TX, and UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.