CXR Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404461 (12CM PS IZ), (2) 72404462 (14CM PS IZ), (3) 72404463 (16CM PS IZ), (4) 72404464 (18CM PS IZ), (5) 72404465 (10CM IP IZ), (6) 72404466 (12CM IP IZ), (7) 72404467 (14CM IP IZ), (8) 72404468 (16CM IP IZ), (9) 72404469 (18CM IP IZ);
Class I - DangerousWhat Should You Do?
- Check if you have this product: 1. UPN: 72404461 (12CM PS IZ); UDI-DI: 00191506021504; Lot numbers: 1100398868, 1100398869, 1100398870, 1100398871, 1100398872, 1100398873, 1100398874, 1100398875, 1100398876, 1100398877, 1100522368, 1100543829, 1100574579, 1100590200, 1100590204, 1100590209, 1100599084, 1100599107, 1100599108, 1100599109, 1100610211, 1100610217, 1100569383, 1100522373, 1100543834, 1100543827, 1100522371, 1100522370, 1100522369, 1100522365, 1100574581, 1100543831, 1100574584, 1100522367, 1100569385, 1100522374, 1100574582, 1100578423, 1100543828, 1100574580, 1100578426, 1100578429, 1100522372, 1100568487, 1100604371, 1100590208, 1100604359, 1100599081, 1100610213, 1100604362, 2. UPN: 72404462 (14CM PS IZ); UDI-DI: 00191506021511; Lot numbers: 1100489498, 1100489542, 1100489543, 1100489544, 1100489547, 1100489549, 1100543855, 1100543857, 1100599134, 1100599138, 1100599195, 1100599201, 1100599204, 1100602511, 1100602512, 1100602514, 1100602561, 1100602563, 1100602566, 1100605702, 1100605706, 1100605714, 1100605715, 1100609592, 1100613514, 1100621453, 1100621454, 1100625387, 1100625388, 1100625391, 1100522433, 1100489493, 1100489492, 1100489495, 1100543858, 1100489546, 1100489494, 1100489496, 1100543859, 1100543864, 1100489497, 1100625392, 1100625394, 1100613511, 1100605718, 1100625393, 1100602694, 1100599203, 1100609585, 1100602695, 1100605709, 1100605710, 1100602564, 1100599196, 1100677511, 1100677506, 1100677507, 1100677509, 1100715069, 3. UPN: 72404463 (16CM PS IZ); UDI-DI: 00191506021528; Lot numbers: 1100480549, 1100480555, 1100480559, 1100480561, 1100480562, 1100480567, 1100492188, 1100511647, 1100511648, 1100511652, 1100511653, 1100511654, 1100511655, 1100511705, 1100511711, 1100546879, 1100546880, 1100546881, 1100551274, 1100551275, 1100551276, 1100551280, 1100560945, 1100560950, 1100565155, 1100565156, 1100565163, 1100565574, 1100565578, 1100565579, 1100565580, 1100565629, 1100565632, 1100565634, 1100565635, 1100602136, 1100602140, 1100602194, 1100602195, 1100602197, 1100602227, 1100602228, 1100602229, 1100605207, 1100605211, 1100605214, 1100614920, 1100615585, 1100615587, 1100619169, 1100619173, 1100619174, 1100657322, 1100657324, 1100657325, 1100511649, 1100565159, 1100511709, 1100560952, 1100480550, 1100480568, 1100565581, 1100492184, 1100546878, 1100546876, 1100546877, 1100546875, 1100480557, 1100511650, 1100511704, 1100480553, 1100480552, 1100480558, 1100480551, 1100511702, 1100511651, 1100511703, 1100480556, 1100565631, 1100560953, 1100605206, 1100602225, 1100602196, 1100614923, 1100602192, 1100602223, 1100606735, 1100615594, 1100615588, 1100614926, 1100619170, 1100615590, 1100615589, 1100602193, 1100602199, 1100602201, 1100605210, 1100690401, 1100657331, 1100657330, 1100663408, 1100663399, 1100657326, 4. UPN: 72404464 (18CM PS IZ); UDI-DI: 00191506021535; Lot numbers: 1100591058, 1100591064, 1100591059, 5. UPN: 72404465 (10CM IP IZ); UDI-DI: 00191506021542; Lot numbers: 1100590252, 1100557278, 6. UPN: 72404466 (12CM IP IZ); UDI-DI: 00191506021559; Lot numbers: 1100398535, 1100398536, 1100398537, 1100398538, 1100398539, 1100398540, 1100398541, 1100398542, 1100556794, 1100491464, 1100491466, 1100573736, 1100491465, 1100573773, 1100491472, 1100565103, 1100573739, 1100512182, 1100554190, 1100512180, 1100491470, 1100491471, 1100491467, 1100512183, 1100554188, 1100556786, 1100573737, 1100573738, 1100491463, 1100573774, 1100512181, 1100573732, 1100491469, 1100573730, 1100491468, 1100554187, 1100627360, 1100627357, 1100627355, 1100668336, 1100668329, 1100668337, 7. UPN: 72404467 (14CM IP IZ); UDI-DI: 00191506021566; Lot numbers: 1100492102, 1100554145, 1100569162, 1100569187, 1100574563, 1100585072, 1100626261, 1100512197, 1100554148, 1100492110, 1100512198, 1100569181, 1100572069, 1100569180, 1100556843, 1100554150, 1100569165, 1100556842, 1100492104, 1100574559, 1100569179, 1100569161, 1100554146, 1100492103, 1100512202, 1100512196, 1100574566, 1100572068, 1100569159, 1100556839, 1100512201, 1100569184, 1100626262, 1100585076, 1100626260, 8. UPN: 72404468 (16CM IP IZ); UDI-DI: 00191506021573; Lot numbers: 1100524763, 1100524766, 1100554179, 1100554180, 1100560191, 1100560905, 1100560907, 1100569608, 1100569612, 1100569649, 1100569656, 1100573275, 1100574054, 1100574055, 1100574058, 1100574059, 1100574062, 1100624980, 1100624983, 1100624987, 1100624988, 1100626293, 1100626296, 1100554173, 1100560903, 1100524760, 1100573278, 1100569609, 1100490867, 1100569610, 1100524761, 1100560908, 1100554175, 1100560197, 1100574056, 1100569605, 1100554177, 1100574057, 1100574060, 1100490863, 1100560900, 1100569648, 1100573273, 1100573269, 1100569604, 1100560906, 1100569657, 1100524758, 1100626288, 1100626295, 1100626292, 9. UPN: 72404469 (18CM IP IZ); UDI-DI: 00191506021580; Lot numbers: 1100624977, 1100624974, 1100624975, 1100624978, 1100624969, 1100624976, 1100624970, 1100624973,
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Boston Scientific Corporation
- Reason for Recall:
- The potential for devices to experience inflation and/or deflation performance issues or difficulties.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
CXR Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404461 (12CM PS IZ), (2) 72404462 (14CM PS IZ), (3) 72404463 (16CM PS IZ), (4) 72404464 (18CM PS IZ), (5) 72404465 (10CM IP IZ), (6) 72404466 (12CM IP IZ), (7) 72404467 (14CM IP IZ), (8) 72404468 (16CM IP IZ), (9) 72404469 (18CM IP IZ);
Product Codes/Lot Numbers:
1. UPN: 72404461 (12CM PS IZ); UDI-DI: 00191506021504; Lot numbers: 1100398868, 1100398869, 1100398870, 1100398871, 1100398872, 1100398873, 1100398874, 1100398875, 1100398876, 1100398877, 1100522368, 1100543829, 1100574579, 1100590200, 1100590204, 1100590209, 1100599084, 1100599107, 1100599108, 1100599109, 1100610211, 1100610217, 1100569383, 1100522373, 1100543834, 1100543827, 1100522371, 1100522370, 1100522369, 1100522365, 1100574581, 1100543831, 1100574584, 1100522367, 1100569385, 1100522374, 1100574582, 1100578423, 1100543828, 1100574580, 1100578426, 1100578429, 1100522372, 1100568487, 1100604371, 1100590208, 1100604359, 1100599081, 1100610213, 1100604362, 2. UPN: 72404462 (14CM PS IZ); UDI-DI: 00191506021511; Lot numbers: 1100489498, 1100489542, 1100489543, 1100489544, 1100489547, 1100489549, 1100543855, 1100543857, 1100599134, 1100599138, 1100599195, 1100599201, 1100599204, 1100602511, 1100602512, 1100602514, 1100602561, 1100602563, 1100602566, 1100605702, 1100605706, 1100605714, 1100605715, 1100609592, 1100613514, 1100621453, 1100621454, 1100625387, 1100625388, 1100625391, 1100522433, 1100489493, 1100489492, 1100489495, 1100543858, 1100489546, 1100489494, 1100489496, 1100543859, 1100543864, 1100489497, 1100625392, 1100625394, 1100613511, 1100605718, 1100625393, 1100602694, 1100599203, 1100609585, 1100602695, 1100605709, 1100605710, 1100602564, 1100599196, 1100677511, 1100677506, 1100677507, 1100677509, 1100715069, 3. UPN: 72404463 (16CM PS IZ); UDI-DI: 00191506021528; Lot numbers: 1100480549, 1100480555, 1100480559, 1100480561, 1100480562, 1100480567, 1100492188, 1100511647, 1100511648, 1100511652, 1100511653, 1100511654, 1100511655, 1100511705, 1100511711, 1100546879, 1100546880, 1100546881, 1100551274, 1100551275, 1100551276, 1100551280, 1100560945, 1100560950, 1100565155, 1100565156, 1100565163, 1100565574, 1100565578, 1100565579, 1100565580, 1100565629, 1100565632, 1100565634, 1100565635, 1100602136, 1100602140, 1100602194, 1100602195, 1100602197, 1100602227, 1100602228, 1100602229, 1100605207, 1100605211, 1100605214, 1100614920, 1100615585, 1100615587, 1100619169, 1100619173, 1100619174, 1100657322, 1100657324, 1100657325, 1100511649, 1100565159, 1100511709, 1100560952, 1100480550, 1100480568, 1100565581, 1100492184, 1100546878, 1100546876, 1100546877, 1100546875, 1100480557, 1100511650, 1100511704, 1100480553, 1100480552, 1100480558, 1100480551, 1100511702, 1100511651, 1100511703, 1100480556, 1100565631, 1100560953, 1100605206, 1100602225, 1100602196, 1100614923, 1100602192, 1100602223, 1100606735, 1100615594, 1100615588, 1100614926, 1100619170, 1100615590, 1100615589, 1100602193, 1100602199, 1100602201, 1100605210, 1100690401, 1100657331, 1100657330, 1100663408, 1100663399, 1100657326, 4. UPN: 72404464 (18CM PS IZ); UDI-DI: 00191506021535; Lot numbers: 1100591058, 1100591064, 1100591059, 5. UPN: 72404465 (10CM IP IZ); UDI-DI: 00191506021542; Lot numbers: 1100590252, 1100557278, 6. UPN: 72404466 (12CM IP IZ); UDI-DI: 00191506021559; Lot numbers: 1100398535, 1100398536, 1100398537, 1100398538, 1100398539, 1100398540, 1100398541, 1100398542, 1100556794, 1100491464, 1100491466, 1100573736, 1100491465, 1100573773, 1100491472, 1100565103, 1100573739, 1100512182, 1100554190, 1100512180, 1100491470, 1100491471, 1100491467, 1100512183, 1100554188, 1100556786, 1100573737, 1100573738, 1100491463, 1100573774, 1100512181, 1100573732, 1100491469, 1100573730, 1100491468, 1100554187, 1100627360, 1100627357, 1100627355, 1100668336, 1100668329, 1100668337, 7. UPN: 72404467 (14CM IP IZ); UDI-DI: 00191506021566; Lot numbers: 1100492102, 1100554145, 1100569162, 1100569187, 1100574563, 1100585072, 1100626261, 1100512197, 1100554148, 1100492110, 1100512198, 1100569181, 1100572069, 1100569180, 1100556843, 1100554150, 1100569165, 1100556842, 1100492104, 1100574559, 1100569179, 1100569161, 1100554146, 1100492103, 1100512202, 1100512196, 1100574566, 1100572068, 1100569159, 1100556839, 1100512201, 1100569184, 1100626262, 1100585076, 1100626260, 8. UPN: 72404468 (16CM IP IZ); UDI-DI: 00191506021573; Lot numbers: 1100524763, 1100524766, 1100554179, 1100554180, 1100560191, 1100560905, 1100560907, 1100569608, 1100569612, 1100569649, 1100569656, 1100573275, 1100574054, 1100574055, 1100574058, 1100574059, 1100574062, 1100624980, 1100624983, 1100624987, 1100624988, 1100626293, 1100626296, 1100554173, 1100560903, 1100524760, 1100573278, 1100569609, 1100490867, 1100569610, 1100524761, 1100560908, 1100554175, 1100560197, 1100574056, 1100569605, 1100554177, 1100574057, 1100574060, 1100490863, 1100560900, 1100569648, 1100573273, 1100573269, 1100569604, 1100560906, 1100569657, 1100524758, 1100626288, 1100626295, 1100626292, 9. UPN: 72404469 (18CM IP IZ); UDI-DI: 00191506021580; Lot numbers: 1100624977, 1100624974, 1100624975, 1100624978, 1100624969, 1100624976, 1100624970, 1100624973,
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0143-2026
Related Recalls
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