Boston Scientific brand Neuro Renegade Hi-Flo Microcatheter, 150cm/20cm; Rx Only; Model Numbers: 182880US, 182890US, 182900US, 182910US; Product is distributed by Boston Scientific Corporation, Natick, MA; Product is manufactured by Boston Scientific Corporation, Cork, Ireland
- Company
- Boston Scientific Corporation
- Recall Initiated
- August 24, 2009
- Posted
- November 15, 2010
- Terminated
- February 3, 2011
- Recall Number
- Z-0357-2011
- Firm Location
- Fremont, CA
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.
Distribution
Distribution Worldwide, including throughout the US.
Lot / Code Info
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,
Root Cause
Packaging process control
Action Taken
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.