Devices

Device Recall PREFACE

  • Model / Serial
    Lot numbers: L0103107, L0103244, L0206088, L0306027, L0306082, L0405345, L0704269, L0804090, L0902372, L1002091 & L1004055
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution, including USA, Australia, Brazil, Canada, China, Colombia, Hong Kong, Indonesia, Israel, India, Japan, Korea, the Netherlands, New Zealand, Pakistan, Singapore, Thailand, and Taiwan.
  • Product Description
    Biosense Webster PREFACE Guiding Sheath, Anterior, for the introduction of intravascular electrophysiology catheters into any cardiac chamber. Catalog Number 301803A
  • Manufacturer
    Biosense Webster, Inc.
  • 1 Event

Manufacturer

Biosense Webster, Inc.
  • Manufacturer Address
    Biosense Webster, Inc., 15715 Arrow Hwy, Irwindale CA 91706-2006
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA

4 devices with a similar name

Learn more about the data here

Device Recall PREFACE
  • Model / Serial
    Lot numbers: 13070991,  13073870,  13073873,  13080117,  13082797 ,  13090941, 13099292,  13103566,  13109369, L0103032, L0103066, L0103069,  L0103295,  L0105007,  L0106017, L0106161,  L0106271, L0203066, L0206045, L0206152, L0206235,  L0206249, L0304237, L0306029,  L0306084, L0306161, L0306209, L0404116, L0502384, L0502568, L0504042,  L0602226, L0604089, L0704070, L0804173,  L0902370, L0902618, L0904056,  L0904071, L0904089, L0904134,  L0904150,  L1002219, L1004025, L1004057,  L1004259, L1102088, L1102219, L1205135 & L1205189
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution, including USA, Australia, Brazil, Canada, China, Colombia, Hong Kong, Indonesia, Israel, India, Japan, Korea, the Netherlands, New Zealand, Pakistan, Singapore, Thailand, and Taiwan.
  • Product Description
    Biosense Webster PREFACE Guiding Sheath, Multipurpose Short, for the introduction of intravascular electrophysiology catheters into any cardiac chamber. Catalog Number 301803MS
  • Manufacturer
    Biosense Webster, Inc.
Device Recall PREFACE
  • Model / Serial
    Lot numbers: 13070988, 13070989, 13070990, 13076034, 13076424, 13078567, 13080115, 13080116, 13082796, 13085573, 13085574, 13088352, 13088353, 13091447, 13093420, 13093421, 13096355, 13099291, 13109368, L0104097, L0104215, L0104266, L0105104, L0105214, L0106131, L0106132, L0106208, L0106234, L0106270, L0106285, L0204006,  L0204061, L0204111, L0204167, L0204238, L0205091,  L0205143, L0205192, L0206043, L0206068, L0206124, L0206125, L0206151, L0206191, L0206192, L0206218, L0206219, L0206234, L0304028, L0304057, L0304183, L0304236, L0304299, L0306043, L0306063, L0306083, L0306110, L0306158, L0306159, L0306208, L0306283, L0404094, L0404117, L0404178, L0503121, L0503213, L0504077,  L0504275,  L0505136,  L0505137,  L0505220,  L0505268, L0603074, L0603133, L0603177, L0603236, L0604058,  L0604088,  L0604144, L0604188, L0604208,  L0604209,  L0604210,  L0604241, L0605013, L0605214, L0702464,  L0704071,  L0704146, L0704226,  L0704270,  L0704299, L0802069, L0803131, L0804040,  L0804100, L0804171,  L0804296,  L0805078,  L0805118,  L0805163,  L0805226, L0902225, L0902617, L0903105, L0903142, L0903195, L0904055, L0904070,  L0904133,  L0904149,  L0904191,  L0904224,  L0905030,  L0905120,  L1002270, L1003019, L1003256, L1004024,  L1 004056,  L1004186,  L1005083,  L1005085,  L1005200, L1005274, L1103144,  L1104011,  L1104268,  L1105121,  L1203210, L1204008,  L1205168, L1205169, L204167 & LO604088
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution, including USA, Australia, Brazil, Canada, China, Colombia, Hong Kong, Indonesia, Israel, India, Japan, Korea, the Netherlands, New Zealand, Pakistan, Singapore, Thailand, and Taiwan.
  • Product Description
    Biosense Webster PREFACE Guiding Sheath, Multipurpose 62cm, for the introduction of intravascular electrophysiology catheters into any cardiac chamber. Catalog Number 301803M
  • Manufacturer
    Biosense Webster, Inc.
Device Recall PREFACE
  • Model / Serial
    Lot numbers: 13073872,  13078568,  13082798,  13084602,  13088356,  13096358,  40206984, 40604122, 40804442,  50205751, 50306355,  50403002,  50405034,  51104857,  A0105904,  A0106063,  A0206419, A1102924, X0105497,  X0205439,  X0305391,  X0306127, X0306956,  X0405043,  X0505118,  X0704423, X0802743, X0805081 & X0905452
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution, including USA, Australia, Brazil, Canada, China, Colombia, Hong Kong, Indonesia, Israel, India, Japan, Korea, the Netherlands, New Zealand, Pakistan, Singapore, Thailand, and Taiwan.
  • Product Description
    Biosense Webster PREFACE Guiding Sheath, Multipurpose 77cm, for the introduction of intravascular electrophysiology catheters into any cardiac chamber. Catalog Number 301805M
  • Manufacturer
    Biosense Webster, Inc.
Device Recall PREFACE
  • Model / Serial
    Lot numbers: 13073871, 13085576, L0103109, L0203006, L0206046, L0206153, L0306085, L0504274, L0604126, L0702465, L0704300, L0802224, L0802580, L0804091 & L0902619
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution, including USA, Australia, Brazil, Canada, China, Colombia, Hong Kong, Indonesia, Israel, India, Japan, Korea, the Netherlands, New Zealand, Pakistan, Singapore, Thailand, and Taiwan.
  • Product Description
    Biosense Webster PREFACE Guiding Sheath, Posterior, for the introduction of intravascular electrophysiology catheters into any cardiac chamber. Catalog Number 301803P
  • Manufacturer
    Biosense Webster, Inc.