Boston Scientific Corporation
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loose connection or complete disconnection. May lead to difficulty connecting syringe, inability to aspirate or inject properly, fluid leakage, or separation of the syringe from the system, potentially requiring device exchange and prolonging the procedure.
Rapid Refill Continuous Injection System, UPN M00566001
UDI-DI (GTIN) 08714729285151 Lots 33786611, 33825949, 33826026, 33949916, 33968571, 33968575, 34079981, 34153104, 34153413, 34153415, 34203075, 34203077, 34153411, 34203079, 34203115, 34386605, 34386609, 34386613, 34429656, 34429658, 34595249, 34693559, 34616613, 34616615, 34712433, 34763427, 34763967, 34805723, 34805725, 34805729, 35006995, 35006999, 35056793, 35208946, 35186845, 35208950, 35397314, 35208952, 35305436, 35498030, 35448316, 35498028, 35551523, 35626939, 35574463, 35688118, 35688460, 35828714,35831703, 35848483, 35877768, 35995282, 36049415, 36159194, 36219882, 36294100, 36303614, 36332230, 31177006, 31180206, 31666278, 31329922, 31356107, 31666276, 31798400, 31798133, 31798135, 31798137, 31852246, 32162450, 32208753, 32255526, 32255528, 32496142, 32661870, 32696046, 32696050, 32696052, 32752697, 32773682, 32791475, 32791477, 32820865, 32838612, 32791479, 33119798, 32977346, 32977348, 33030942, 33120320, 33158008, 33158006, 33354311, 33354315, 33354317, 33403248, 33403252, 33696882, 33696884, 33696886, 33696888, 33750883, 33750885, 33750887, 36332232, 36497262, 36159192, 36587704, 36612263, 36739668, 36785215, 36785217, 36814560, 36845486, 36983883, 36983886, 37291592, 37059471, 37417957, 37417959, 37429808, 37456936, 37472523, 37585745, 37627037, 37654892, 37941477, 37974508, 38033021, 38033023, 38124799, 38143635, 38165214, 38182214, 38201123, 37959187, 38353956, 38374833, 38430201, 33968573, 34386611, 32838610, 38205377, 38429054, 34066207, 34429654, 34616611, 34712429, 34763971, 34805727, 35006997, 35448312, 35448314, 35626937, 35688021, 35848481, 35687399, 31616842, 31601573, 31616848, 31616850, 31616846, 32208755, 32455154, 35877766, 36776858, 37037796, 37200706, 37276220, 37291594, 37639238, 38154387, 35305438, 31797614, 33354313, 33696890, 36470789, 37309672, 37396601, 37407323, 37472521, 35056797, 35626933, 33786613, 33825951, 33950422, 34965218, 35056795, 36101020, 36100418, 31356105, 32208759, 32661868, 33030940, 33679650, 37059473, 37041524, 37633157, 37991645, 38137850, 38393609, 33968569, 34703963, 36319481, 33649863, 37019542, 37493275, 34616609, 34386607, 34763969, 34805721, 35942747, 31852244, 32977350, 33354319, 37884043, 38001944, 32752695, 37189280, 37612931, 38703180, 34429700, 33968567, 34017321, 34568306, 34712431, 34873735, 34873737, 34965420, 35007081, 35186843, 35208948, 35397312, 35448310, 35305600, 35626935, 35778515, 35778517, 35778513, 35989120, 36027670, 36049413, 36303612, 36319483, 36312073, 36353951, 36437019, 36517931, 36409546, 36537384, 36622267, 36750117, 36750119, 36994750, 36962014, 37407325, 37456934, 37766480, 37660978, 37764898, 37723376, 37991643, 38856580, 38178214, 38337853, 38326961, 38410111, 38414293, 38576233, 38586789, 38622115, 38633220, 38676778, 38649491, 38680582, 38864691, 38687308, 38876174, 38901702, 31170922, 31601571, 31616844, 31852242, 31852240, 32162448, 32208757, 32696048, 32723872, 32723874, 32838608, 32964550, 32977344, 33119794, 33119796, 33257466, 33334705, 33403250, 33649865, 33933383
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →