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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.

FDA Recall Z-2090-2014 · Posted 2014-07-22

Recalling FirmZoll Circulation, Inc.
Recall StatusTerminated
Product CodeDRM
Date Initiated2013-07-16
Date Terminated2014-07-22
Product Quantity161 Nickel Metal batteries, 40 LifeBand

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.

Firm Action

Zoll Japan handled the recall.

Root Cause

Labeling Change Control

Distribution Pattern

Distributed in Japan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K040453AUTOPULSE RESUSCITATION SYSTEM, MODEL 100Revivant Corp. · 2004-03-11K032852MODIFICATION TO: AUTOPULSE RESUSCITATION SYSTEM MODEL 100Revivant Corp. · 2003-11-12K022345AUTOPULSE RESUSCITATION SYSTEMRevivant Corp. · 2002-08-15K011046AUTOPULSE, MODEL 100Revivant Corp. · 2001-10-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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