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Class 2 Device Recall Ultra2 Cutting Balloon |
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Date Initiated by Firm |
July 21, 2006 |
Date Posted |
September 23, 2006 |
Recall Status1 |
Terminated 3 on February 03, 2007 |
Recall Number |
Z-1512-06 |
Recall Event ID |
35939 |
PMA Number |
P950020 |
Product Classification |
Cutting Ballon - Product Code LOX
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Product |
Boston Scientific Cutting Balloon Ultra2 Monorail Device, Boston Scientific, One Boston Scientific Place, Natick, MA 01760. |
Code Information |
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. |
Recalling Firm/ Manufacturer |
Boston Scientific 1 Scimed Pl Maple Grove MN 55311-1565
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Manufacturer Reason for Recall |
Lack of assurance of sterility (pre-sterilization bioburden limits exceeded)
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FDA Determined Cause 2 |
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 product return instructions. |
Quantity in Commerce |
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. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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PMA Database |
PMAs with Product Code = LOX and Original Applicant = Boston Scientific Corp.
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