Agency classClass IOur severity:Severe FDA (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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "GE Healthcare has recently become aware of a potential safety issue due to air leakage associated with the CO2 Multi Absorber."

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: air-leakage

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:

Same manufacturer · GE Healthcare, LLC

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