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U.S. Department of Health and Human Services

Class 3 Device Recall LifeBand Single Pack (accessory), and Nickelmetal hydride (NIMH) Battery.

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 Class 3 Device Recall LifeBand Single Pack (accessory), and Nickelmetal hydride (NIMH) Battery.see related information
Date Initiated by FirmJuly 16, 2013
Date PostedJuly 22, 2014
Recall Status1 Terminated 3 on July 22, 2014
Recall NumberZ-2090-2014
Recall Event ID 68718
510(K)NumberK011046 K022345 K032852 K040453 
Product Classification Compressor, cardiac, external - Product Code DRM
ProductZoll 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.
Code Information 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.
Recalling Firm/
Manufacturer		 Zoll Circulation, Inc.
2000 Ringwood Ave
San Jose CA 95131-1728
For Additional Information ContactMichael Chibbaro
408-541-2140
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Labeling Change Control
ActionZoll Japan handled the recall.
Quantity in Commerce161 Nickel Metal batteries, 40 LifeBand
DistributionDistributed in Japan.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DRM
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