Device Recall Tubing Pack

  • Modèle / numéro de série
    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
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    DE, IA, CA and Japan
  • Description du dispositif
    Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Medtronic Perfusion Systems, 7611 Northland Dr N, Brooklyn Park MN 55428-1088
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA