Recall Z-0903-2009 ยท OEX Cardiovascular Catheter Sheath Introducer Kit
Spectranetics Corporation
Spectranetics SLS II 14Fr. Laser Sheath Kit, REF 500-012, Sterile EO, individually packaged, Lot number 080314B, Spectranetics, 96 Talamine Court, Colorado Springs, Colorado 80907. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.
| Date | Jan 30, 2009 (initiated Oct 15, 2008) |
| Status | Terminated |
| Reason | Catheter pouch was mislabeled with the wrong size. |
| Root cause | Error in labeling |
| Action | Consignees were notified by sales representatives who visually inspected their inventory. The sales representatives were given a form to fill out to confirm whether the consignee had the catheters with the serial number still in inventory. The forms were faxed back to Spectranetics indicating if the catheters were used or not and if they were not used, were they labeled correctly. For assistance, contact Spectranetics Corporation at 1-719-447-2319. |
| Quantity | 24 units |
| Distribution | CA, FL, MI, NC, NY, OH, PA, TX, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.