Presource kits and trays, labeled as: 1) Neurological Tray, Catalog Number SAN29NICCA; 2) Neurological Tray, Catalog Number SAN29NRCC1; 3) Neurological Tray, Catalog Number SAN29NRCC2; 4) Neurological Tray, Catalog Number SAN29NRCC3; 5) Neurological Tray, Catalog Number SAN29NRCCA; 6) Neurological Tray, Catalog Number SANV1NIYH2; 7) Neurological Tray, Catalog Number SANV1NIYH3; 8) Neurological Tray, Catalog Number SANV1NIYH4; 9) Neurological Tray, Catalog Number SANV1NIYH5; 10) Neurological Tray, Catalog Number SANV1NIYH6; 11) Neurological Tray, Catalog Number SANV1NIYH7; 12) Neurological Tray, Catalog Number SANV1NIYHD; 13) Neurological Tray, Catalog Number SANV1NIYHE; 14) Neurological Tray, Catalog Number SANV1NIYHF; 15) Neurological Tray, Catalog Number SANV2INEH4; 16) Neurological Tray, Catalog Number SANV2INEHG; 17) Neurological Tray, Catalog Number SANV2INEHH; 18) Neurological Tray, Catalog Number SNE29NRCCC; 19) Neurological Tray, Catalog Number SNECGMEUCA; 20) Neurological Tray, Catalog Number SNECGNIUC3; 21) Neurological Tray, Catalog Number SNECGNIUCA; 22) Neurological Tray, Catalog Number SNEMHNTWD1; 23) Neurological Tray, Catalog Number SNEMHNTWDA
Publicado el 17 de julio de 2024 · Inicio del retiro: 29 de mayo de 2024
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical¿ supplied finished kits. Merit Medical¿ supplied finished kits are included as components in Presource kits. According to the FDA s communication, these Shenli syringes, located inside a Merit Medical¿ kit component, cannot be distributed for use as they could contain a significant change or modification in design which could significantly alter the safety or effectiveness of the finished kit product, resulting in the risk of patient harm such as inaccurate dosing and a leaking device.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Cardinal Health 200, LLC
- Distribuidor
- Nationwide
- Lote
- 1) SAN29NICCA, UDI/DI (CS/EA) 50197106228256/10197106228258, Lot Numbers: 36457; 2) SAN29NRCC1, UDI/DI (CS/EA) 50888439733509/10888439733501, Lot Numbers: 381858; 3) SAN29NRCC2, UDI/DI (CS/EA) 50195594325563/10195594325565, Lot Numbers: 685160; 4) SAN29NRCC3, UDI/DI (CS/EA) 50195594622532/10195594622534, Lot Numbers: 801575; 5) SAN29NRCCA, UDI/DI (CS/EA) 50888439636374/10888439636376, Lot Numbers: 28512, 42260, 69660, 85314, 103254, 127809, 140829, 183868, 213751, 227923, 240464, 251395, 268874, 345018, 393999, 409767, 428188, 443499, 450337, 493647, 516110, 532267, 558093, 579539, 607101, 629107, 653793, 713103, 736984, 760148, 840293, 860356, 884815, 911567, 927802, 951008, 972525; 6) SANV1NIYH2, UDI/DI (CS/EA) 50195594812117/10195594812119, Lot Numbers: 900859; 7) SANV1NIYH3, UDI/DI (CS/EA) 50195594854292/10195594854294, Lot Numbers: 910887; 8) SANV1NIYH4, UDI/DI (CS/EA) 50197106022526/10197106022528, Lot Numbers: 935906; 9) SANV1NIYH5, UDI/DI (CS/EA) 50197106182060/10197106182062, Lot Numbers: 8317; 10) SANV1NIYH6, UDI/DI (CS/EA) 50197106184606/10197106184608, Lot Numbers: 10606; 11) SANV1NIYH7, UDI/DI (CS/EA) 50197106550302/10197106550304, Lot Numbers: 206131; 12) SANV1NIYHD, UDI/DI (CS/EA) 50888439951804/10888439951806, Lot Numbers: 586552, 619022, 623318, 643076, 665586, 708746, 735601, 759729, 779438, 791843, 822259, 841189, 863424, 884486, 892439, 952549, 960592, 980278, 982298; 13) SANV1NIYHE, UDI/DI (CS/EA) 50197106142910/10197106142912, Lot Numbers: 141514; 14) SANV1NIYHF, UDI/DI (CS/EA) 50197106482221/10197106482223, Lot Numbers: 157881, 168214, 228005, 237862, 262336, 267274; 15) SANV2INEH4, UDI/DI (CS/EA) 50197106029129/10197106029121, Lot Numbers: 937561; 16) SANV2INEHG, UDI/DI (CS/EA) 50195594755414/10195594755416, Lot Numbers: 927680; 17) SANV2INEHH, UDI/DI (CS/EA) 50197106029365/10197106029367, Lot Numbers: 8892, 10096, 14350, 36037, 120832, 134410, 215368, 224862, 238592, 243572, 967590; 18) SNE29NRCCC, UDI/DI (CS/EA) 50887488772705/10887488772707, Lot Numbers: 236962, 236962, 256027, 257466, 287291, 287291, 318482; 19) SNECGMEUCA, UDI/DI (CS/EA) 50197106387724/10197106387726, Lot Numbers: 98094, 156243; 20) SNECGNIUC3, UDI/DI (CS/EA) 50197106605873/10197106605875, Lot Numbers: 238196; 21) SNECGNIUCA, UDI/DI (CS/EA) 50197106045525/10197106045527, Lot Numbers: 48591, 172310, 203428, 223186, 247687, 265553, 980874; 22) SNEMHNTWD1, UDI/DI (CS/EA) 50197106251780/10197106251782, Lot Numbers: 37065; 23) SNEMHNTWDA, UDI/DI (CS/EA) 50195594826039/10195594826031, Lot Numbers: 129007, 163637, 206874, 938377, 972171
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
¿Vendes productos como este?
Recalert vigila todo tu catálogo contra retiros como este, automáticamente.