Agency classClass IIIOur severity:Low FDA (Devices)·Z-2090-2014·Announced 2014-07-30

Zoll Circulation Recalls AutoPulse Accessories Due to Japanese Label Typo

Zoll Circulation is recalling 161 NiMH batteries and 40 LifeBand packs distributed in Japan due to a typographical error on the Japanese legal label.

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a typographical error on a label, which falls under the 'Low' severity criteria for documentation or packaging-only problems.

Plain-English summary

Zoll Circulation, Inc. is recalling 161 Nickel-metal hydride (NIMH) batteries and 40 LifeBand Single Packs. These products are accessories for the AutoPulse Resuscitation System Model 100, which is used for chest compressions as an adjunct to manual CPR.

The recall was initiated because of a typographical error found on the Japanese legal label of the AutoPulse Resuscitation System Model 100. The affected label is specific to the Japanese version of the product.

The recalled items were distributed in Japan. The specific products involved are the LifeBand Single Pack (product code 8700-03, lot 41515) and the Nickel-metal hydride battery (product code 8700-0702-03) with specific serial numbers listed in the agency record. Consumers in Japan should check their product labels and contact the manufacturer for instructions.

The recalled product

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…
Manufacturer: Zoll Circulation, Inc.
Category: Medical Device — Resuscitation Accessories
Hazard: mis-labeling

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

Distribution

Distribution scope not specified by the agency.

Same manufacturer · Zoll Circulation, Inc.

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Same hazard · mis labeling