Reported Jul 30, 2014 · Terminated
Zoll Circulation LifeBand Single Pack (accessory), and Nickel-metal hydride (NIMH) Battery. The LifeBand is a chest…
Zoll Circulation, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zoll Circulation, Inc. · 2000 Ringwood Ave · San Jose, CA · 95131-1728
Is this the product you have?
- 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.
- Lot codes and dates
- LifeBand Single Pack
product code 8700-03lot 41515
- Nickel-Metal hyride batteryproduct
- code 8700-0702-03serial
- numbers
161 of 161 codes
036900369503696037000370103702037060370703708037090371003711037150371703718037200372103726037270372803730037320373303734037360373803742037430374503749037500375803768037700377203773037780377903781037820378303786037880379703799038050380603809038630386603867038690387103874038750388003881038820388303888
- LifeBand Single Pack
- Amount recalled
- 161 Nickel Metal batteries, 40 LifeBand
Why it was 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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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