Boston Scientific Cutting Balloon Ultra2 Monorail Device, Boston Scientific, One Boston Scientific Place, Natick, MA 01760.
This recall has been terminated (originally issued September 23, 2006).
- Company
- Boston Scientific
- Recall Initiated
- July 21, 2006
- Posted
- September 23, 2006
- Terminated
- February 3, 2007
- Recall Number
- Z-1512-06
- Quantity
- 1,000
- Firm Location
- Maple Grove, MN
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of assurance of sterility (pre-sterilization bioburden limits exceeded)
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.
Lot / Code Info
Material Number (UPN) / Catalog Number / Lot/Batch #: H749CBM200060 / CBM20006 / EG0438 & EG0499; H749CBM200100 / CBM20010 / EG0427; H749CBM225060 / CBM22506 / EG0448 & EG0471; H749CBM225100 / CBM22510 / EG0444 & EG0502; H749CBM250060 / CBM25006 / EG0439 & EG0472; H749CBM250100 / CBM25010 / EGO425, EG0440, EG0474 & EG0475; H749CBM250150 / CBM25015 / EG0466; H749CBM275060 / CBM27506 / EG0420 & EG0487; H749CBM275100 / CBM27510 / EG0419 & EG0456; H749CBM275150 / CBM27515 / EG0424; H749CBM300060 / CBM30006 / EG0423, EG0473 & EG0497; H749CBM300100 / CBM30010 / EG0426, EG0441, EG0465, EG0485; H749CBM300150 / CBM30015 /EG0443 & EG0418; H749CBM325060 / CBM32506 / EG0500; H749CBM325100 / CBM32510 / EG0422 & EG0501; H749CBM325150 / CBM32515 / EG0467; H749CBM350060 / CBM35006 / EG0437; H749CBM350100 / CBM35010 / EG0349, EG0428, EG0468; H749CBM350150 / CBM35015 / EG0421 & EG0486; H749CBM375060 / CBM37506 / EG0503; H749CBM375100 / CBM37510 / EG0457; H749CBM375150 / CBM37515 / EG0455; H749CBM400060 / CBM40006 / EG0504; H749CBM400100 / CBM40010 / EG0442 & EG0498; H749CBM400150 / CBM40015 / EG0476.
Root Cause
Other
Action Taken
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 product return instructions.