Events

Recall of Device Recall LifeBand Single Pack (accessory), and Nickelmetal hydride (NIMH) Battery.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zoll Circulation, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    68718
  • Event Risk Class
    Class 3
  • Event Number
    Z-2090-2014
  • Event Initiated Date
    2013-07-16
  • Event Date Posted
    2014-07-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-07-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128557
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Compressor, cardiac, external - Product Code DRM
  • Reason
    Typographical error in the japanese legal label of the autopulse resuscitation system model 100. the label is specific to the japanese version of the product.
  • Action
    Zoll Japan handled the recall.

Device

Device Recall LifeBand Single Pack (accessory), and Nickelmetal hydride (NIMH) Battery.
  • Model / Serial
    LifeBand Single Pack: product code 8700-03, lot 41515; Nickel-Metal hyride battery: product code 8700-0702-03: serial numbers: 03690,03695,03696,03700,03701,03702,03706,03707,03708,03709,03710, 03711,03715,03717,03718,03720,03721,03726,03727,03728,03730,03732, 03733,03734,03736,03738,03742,03743,03745,03749,03750,03758,03768, 03770,03772,03773,03778,03779,03781,03782,03783,03786,03788,03797, 03799,03805,03806,03809,03863,03866,03867,03869,03871,03874,03875, 03880,03881,03882,03883,03888,03889,03890,03893,03894,03895,03896, 03899,03901,03906,03910,03916,03926,03943,04064,04067,04100,04119, 04133,04193,04223,04233,04301,04303,04304,04337,04364,04397,04399, 04400,04405,04406,04408,04409,04410,04411,04415,04417,04418,04419, 04420,04421,04422,04423,04433,04442,04468,04470,04478,04482,04483, 04510,04511,04514,04585,04586,04587,04588,04589,04591,04593,04594, 04595,04596,04598,04599,04600,04603,04607,04608,04610,04611,04612, 04617,04619,04635,04641,04662,04674,04675,04676,04678,04679,04682, 04704,04705,04712,04718,04744,04762,04763,04773,04774,04777,04780, 04782,04785,04786,04789,04795,04828,04838.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in Japan.
  • Product Description
    Zoll Circulation LifeBand Single Pack (accessory), and Nickel-metal hydride (NIMH) Battery. || The LifeBand is a chest compression assembly that consists of a cover plate and two bands integrated with a compression pad with a Velcro fastener. The AutoPulse Battery is a removable component that supplies power for the AutoPulse operation. Used in the AutoPulse Resuscitation System Model 100, for chest compressions as an adjunct to manual CPR.
  • Manufacturer
    Zoll Circulation, Inc.

Manufacturer

Zoll Circulation, Inc.
  • Manufacturer Address
    Zoll Circulation, Inc., 2000 Ringwood Ave, San Jose CA 95131-1728
  • Manufacturer Parent Company (2017)
    Asahi Kasei Corp.
  • Source
    USFDA