Recall Z-1512-06 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Boston Scientific
Boston Scientific Cutting Balloon Ultra2 Monorail Device, Boston Scientific, One Boston Scientific Place, Natick, MA 01760.
| Date | Sep 23, 2006 (initiated Jul 21, 2006) |
| Status | Terminated |
| Reason | Lack of assurance of sterility (pre-sterilization bioburden limits exceeded) |
| Root cause | Other |
| Action | On July 21, 2006, Boston Scientific initiated a voluntary recall of 45 lots/batches of Cutting Balloon Ultra Monorail Devices due to their determination that the lots do not meet their sterilization requirements. There is a remote possibility of infection in the patient. An infection, if it occurred, could be recognized and treated effectively in these patients. Boston Scientific is not aware of any complaints related to this product issue. Letters dated July 21, 2006, were sent to their customers with instructions to cease further distribution, complete and return a tracking form, and p |
| Quantity | 1,000 |
| Distribution | Class II Recall - Nationwide distribution ---- including states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, VT, WA, WI, WV, and WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.