FDAFDA · Alimentos y medicamentos·N.º oficial Z-0535-2018
Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.
Publicado el 14 de febrero de 2018 · Inicio del retiro: 3 de enero de 2018
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Medtronic custom perfusion tubing packs contain Terumo OPS valves that were recalled due to a lack of flow through the valve.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Medtronic Perfusion Systems
- Distribuidor
- DE, IA, CA and Japan
- Lote
- a) REF 2815R1, UPN/GTIN: 20885074191038, Lot/Serial Numbers: 210937492, 213151103, 213671744 b) REF 2D25R6, UPN/GTIN: 00613994268174, Lot/Serial Numbers: 209533592, 209759280, 209948919, 210174899, 210377603, 210478517, 210591995, 210767149, 211011818, 211210404, 211243436, 211542842, 211761616 c) REF 9M68R, UPN/GTIN: 20643169876648, Lot/Serial Numbers: 212067087, 212796361 d) REF BB4B15R13, UPN/GTIN: 00643169845121, Lot/Serial Numbers: 211804184, 212073924, 212266962, 212268301, 212385983, 212552883, 212796215, 213248430, 213583108 e) REF BB4B15R14, UPN/GTIN: 00763000025878, Lot/Serial Numbers: 213801240, 213868837 f) REF BB9L72R, UPN/GTIN: 00643169845077, Lot/Serial Numbers: 211715103 g) REF BB9L72R1, UPN/GTIN: 00643169872127, Lot/Serial Numbers: 212020797, 212174623, 212193001, 212301586, 212355584, 212428238, 212626142, 212884370, 213001157, 213248459, 213631247, 213672934, 213802501, 214072742, 214093025 h) REF CB1Z87R11, UPN/GTIN: 00643169741591, Lot/Serial Numbers: 211755326 i) REF CB4L56R24, UPN/GTIN: 00643169735989, Lot/Serial Numbers: 211654744, 211654745, 211800954 j) REF CB4L56R26, UPN/GTIN: 00643169906181, Lot/Serial Numbers: 212294432, 212404544, 212447345, 212489670, 213251146, 213251166, 213358174, 213573495, 213623995, 214053395 k) REF CB5S68R3, UPN/GTIN: 20613994490760, Lot/Serial Numbers: 210937507 l) REF CB7X82R4, UPN/GTIN: 00643169471986, Lot/Serial Numbers: 211050766, 211320749 m) REF CB7X82R5, UPN/GTIN: 00643169789517, Lot/Serial Numbers: 211423503, 211443209, 211443210, 211885323, 211991293, 212154744, 212235237, 212274655, 212428312, 212473311, 212671632, 212962650, 213126447, 213292357, 213377926, 213445426, 213494394, 213494396, 213672914, 213906498, 214043035, 214093030 n) REF HY6Y19R5, UPN/GTIN: 00643169510432, Lot/Serial Numbers: 210802114, 210945613, 211114272, 211210180, 211327621, 211654742, 211846417, 212235012, 212545229, 212835348 o) REF HY8M65R2, UPN/GTIN: 00643169661295, Lot/Serial Numbers: 210952226, 211335076, 211558225, 211722651, 212028419, 212222066, 212355669, 213001001, 213719738 p) REF TL8W39R6, UPN/GTIN: 00643169715097, Lot/Serial Numbers: 210731697, 210838201, 210937704
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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