PlainRecalls
FDA Devices Low Class III Terminated

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.

Reported: July 30, 2014 Initiated: July 16, 2013 #Z-2090-2014

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.

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.

Details

Recalling Firm
Zoll Circulation, Inc.
Units Affected
161 Nickel Metal batteries, 40 LifeBand
Distribution
Distributed in Japan.
Location
San Jose, CA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Zoll Circulation, Inc.. Units affected: 161 Nickel Metal batteries, 40 LifeBand.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 30, 2014. Severity: Low. Recall number: Z-2090-2014.