The Recall Desk
HighFDA (Devices)·Z-0472-2014·Announced 2013-12-25

GE Healthcare Recalls Multi Absorber Original Devices Due to Air Leakage

GE Healthcare is recalling Multi Absorber Original, Disposable devices due to a potential safety issue involving air leakage associated with the CO2 Multi Absorber.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a potential safety issue (air leakage) where no specific injuries or illnesses are reported in the source text, fitting the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

GE Healthcare, LLC is recalling the Multi Absorber Original, Disposable (Product Number M1173310). The recall is being conducted due to a potential safety issue identified by the company involving air leakage associated with the CO2 Multi Absorber.

The affected products are intended for use with the GE Healthcare Advanced Breathing System, EZchange manifold, Compact Block, and Compact Block II. The devices are intended to be used under the constant attention of qualified professional healthcare personnel. The recall includes lot numbers 12001 through 13031.

The recall covers 59,721 boxes (358,326 canisters) distributed in the United States and 3,724 boxes (22,344 canisters) distributed internationally to Canada, Costa Rica, Mexico, and Venezuela. Healthcare facilities and distributors should stop using the affected devices and contact GE Healthcare for further instructions.

The recalled product

Product
Multi Absorber Original, Disposable M1173310 Multi Absorber Original, Disposable, package of 6 pcs, GE Healthcare Finland Oy Made in US Rx Only The GE Healthcare Multi Absorber Original, Disposable is a disposable product intended for use with the GE Healthcare Advanced
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Anesthesia / Respiratory
Hazard

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 (1)

  • product number M1173310 containing lot numbers 12001 through 13031.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Related recalls

Same manufacturer · GE Healthcare, LLC

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Same hazard · air leakage

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