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U.S. Department of Health and Human Services

Class 2 Device Recall Renegade Fiber Braided Microcatheter

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  Class 2 Device Recall Renegade Fiber Braided Microcatheter see related information
Date Initiated by Firm August 24, 2009
Date Posted November 15, 2010
Recall Status1 Terminated 3 on February 03, 2011
Recall Number Z-0358-2011
Recall Event ID 53048
510(K)Number K973645  
Product Classification Catheter, continuous flush - Product Code KRA
Product Boston Scientific brand Renegade Fiber Braided Microcatheter, 150/10/2RO, Rx Only;
Model Numbers: 18257, 18259; Product is distributed by
Boston Scientific Corporation, Natick, MA;
Product is manufactured by Boston Scientific Corporation, Cork, Ireland
Code Information Lots:  11249879, 11542408, 11750295, 11966695, 12156146, 12228393, 12365497, 12491154,  11253574, 11546053, 11756331, 11988066, 12156147, 12228443, 12365604, 12509751,  11257185, 11552115, 11776786, 11996448, 12156183, 12228444, 12365605, 12509758,  11268801, 11554501, 11793108, 12001306, 12170507, 12248055, 12365613, 12509920,  11271408, 11559603, 11800162, 12001562, 12170508, 12248109, 12365614, 12527317,   11562655,  11274973, 11572313, 11806766, 12001567, 12170516, 12248121, 12385142, 12527760,  11296064, 11573180, 11819657, 12001568, 12175704, 12262088, 12385143, 12527763,  11301389, 11577242, 11825864, 12021328, 12175706, 12270709, 12385158, 12527769,  11303513, 11580376, 11836834, 12028753, 12175708, 12270714, 12385224, 12546795,   11840079,  11307943, 11586443, 11843094, 12039033, 12175710, 12270983, 12402095, 12546199,  11318319, 11587960, 11849818, 12049925, 12175711, 12279662, 12402111, 12546941,  11319596, 11602048, 11857667, 12061129, 12175713, 12292373, 12421265, 12546946,  11423369, 11623809, 11869009

12068930, 12175717, 12296121, 12421267, 12560791,   12073876,  11425310, 11627605, 11876193, 12089556, 12175719, 12296833, 12421271, 12560192  11425314, 11631734, 11880345, 12104631, 12175724, 12297455, 12421274, 12578834  11429065, 11638177, 11884227, 12104678, 12194075, 12311446, 12439946, 12578835  11429069, 11649446, 11891449, 12108064, 12194077, 12311459, 12439951, 12578864   12194829,  11432583, 11656601, 11891458, 12120518, 12194831, 12311520, 12439954, 12614498,  11432584, 11678955, 11895180, 12120528, 12214586, 12326062, 12439958, 12634309,  11441965, 11682874, 11895183, 12123141, 12214589, 12330440, 12458414, 12634310,  11444027, 11695922, 11925162, 12133525, 12214592, 12330441, 12458475, 12634315,   12330443,  11445708, 11703970, 11927490, 12142142, 12214602, 12330465, 12458416, 12659579,  11461698, 11706368, 11933896, 12142150, 12214604, 12330476, 12458543, 12660000,  11469070, 11710717, 11941913, 12148683, 12214616, 12330511, 12458548,  11481564, 11714291, 11948975, 12148684, 12228116, 12348609, 12466721,  11534917, 11721375, 11959863, 12148687, 12228366, 12365495, 12466123,    
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
47900 Bayside Pkwy
Fremont CA 94538-6515
For Additional Information Contact
508-652-5594
Manufacturer Reason
for Recall		 Sterility Loss-- The sterile barrier pouch seal (top seal) may be breached by the product, resulting in loss of sterility which may result in transmission of disease or infection.
FDA Determined
Cause 2		 Packaging process control
Action Boston Scientific issued an Urgent Medical Device Recall letter dated August 26, 2009 identifying the affected devices, the issue prompting the recall, and actions to be taken by customers. Customers were instructed to determine if they have affected product in their inventory, and if so, immediately quarantine and return to Boston Scientific. Customers can contact Boston Scientific at 510 624-1734.
Distribution Distribution Worldwide, including throughout the US.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = KRA and Original Applicant = BOSTON SCIENTIFIC CORP.
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