FDAClass IIIJuly 30, 2014

Zoll Circulation LifeBand Single Pack recall

Zoll Circulation LifeBand Single Pack (accessory), and Nickel-metal hydride (NIMH) Battery. The LifeBand is a chest compression assembly that consists…

Why was Zoll Circulation LifeBand Single Pack recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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
Zoll Circulation LifeBand Single Pack (accessory), and Nickel-metal hydride (NIMH) Battery. The LifeBand is a chest compression assembly that consists…
Recalling firm
Zoll Circulation, Inc.
Quantity
161 Nickel Metal batteries, 40 LifeBand
Distribution
Distributed in Japan.
Recall date
July 30, 2014
Classification
Class III
Status
Terminated
Agency
FDA (device)
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