Device Recall BIOM PACK

  • Modèle / numéro de série
    Cornea Coat Lot Codes:  M408080708,  M409570708,  M414420808,  M415940808,  M415950808,  M416620908,  M419300908,  M421610908,  M421680908,  M422951008,  M427661108,  M430041108,  M435381208,  M442120109,  M44499,  M44744,  M44897.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, including Puerto Rico, and Frankfurt, Germany.
  • Description du dispositif
    BIOM PACK, Contents Individually Sterile. QTY 5 EA. Each Pack Contains: 1 EA. Microscope Drape (REF40100), 1 EA. Cornea Coat (REF 60010), 1 EA. SuperView BIOM Lens Set (REF 40411). || Manufactured by: Insight Instruments, Inc., 2580 SE Willoughby Blvd. Stuart, FL 34994 USA. || Item # 40201: || Item Lot # Cornea Coat Lot # Expiration Date || M423801008 M419300908 2010-07 || M427731108 M419300908 2010-07 || M428631008 M419300908 2010-07 || M434211208 M422951008 2010-08 || M439670109 M422951008 2010-08 || M443700109 M435381208 2010-09 || M44887 M442120109 2010-10 || Item # 40202: || Item Lot # Cornea Coat Lot # Expiration Date || M427641008 M419300908 2010-07 || M45414 M435381208 2010-09 || Item # 40203: || M416600908 M415950808 2010-06 || M422941008 M416620908 2010-07 || M427651108 M422951008 2010-08 || M442710109 M435381208 2010-09 || M44870 M442120109 2010-10 || Item # 40204: || Item Lot # Cornea Coat Lot # Expiration Date || M421580908 M416620908 2010-07 || M435201208 M422951008 2010-08 || M45645 M435381208 2010-09 || Item # 40205: || Item Lot # Cornea Coat Lot # Expiration Date || M410510708 M409570708 2010-05 || M412790708 M409570708 2010-05 || M419280908 M415950808 2010-06 || M420850908 M415950808 2010-06 || M421100908 M416620908 2010-07 || M421120908 M416620908 2010-07 || M424361008 M419300908 2010-07 || M425821008 M421680908 2010-07 || M426731008 M421680908 2010-07 || M428601008 M419300908 2010-07 || M429531108 M421680908 2010-07 || M430851108 M421680908 2010-07 || M431051108 M422951008 2010-08 || M433111108 M422951008 2010-08 || M435531208 M430041108 2010-09 || M440700109 M430041108 2010-09 || M441790109 M435381208 2010-09 || M442560109 M430041108 2010-09 || M443450109 M422951008 2010-08 || M443930109 M442120109 2010-10 || M44605 M442120109 2010-10 || M44896 M44499 2010-11 || M45099 M44499 2010-11 || M45243 M435381208 2010-09 || M45248 M44897 2010-12 || M45866 M44897 2010-12 || M45870 M435381208 2010-09 || Item # 10206: || Item Lot # Cornea Coat Lot # Expiration Date || M418460908 M416620908 2010-07 || M434741208 M422951008 2010-08 || M45646 M435381208 2010-09
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Insight Instruments, Inc., 2580 Se Willoughby Blvd, Stuart FL 34994-4701
  • Société-mère du fabricant (2017)
  • Source
    USFDA