Recall Z-2090-2014— Zoll Circulation, Inc.

Name: FDA recall Z-2090-2014
Creator: U.S. Food and Drug Administration
Published: 2013-07-16

Class III · Terminated

Class III FDA medical device recall by Zoll Circulation, Inc., initiated 2013-07-16, terminated 2014-07-22. It names 4 FDA 510(k) clearances: K040453, K032852, K022345 and 1 more. Product: 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: 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..

Recalling firm: Zoll Circulation, Inc.
Classification: Class III
Status: Terminated
Initiated: 2013-07-16
Terminated: 2014-07-22
Firm location: San Jose, CA, United States

510(k) clearances named in this recall

4 on FDA's record

K040453 — AUTOPULSE RESUSCITATION SYSTEM, MODEL 100Revivant Corp.·cleared 2004-03-11
K032852 — MODIFICATION TO: AUTOPULSE RESUSCITATION SYSTEM MODEL 100Revivant Corp.·cleared 2003-11-12
K022345 — AUTOPULSE RESUSCITATION SYSTEMRevivant Corp.·cleared 2002-08-15
K011046 — AUTOPULSE, MODEL 100Revivant Corp.·cleared 2001-10-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.