PlainRecalls
FDA Devices Critical Class I Terminated

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 Breathing System (later ABS), the GE Healthcare EZchange manifold, the GE Healthcare Compact Block, and the GE Healthcare Compact Block II (later Compact Block). The Multi Absorber should only be used with air, oxygen, n

Reported: December 25, 2013 Initiated: September 19, 2013 #Z-0472-2014

Product Description

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 Breathing System (later ABS), the GE Healthcare EZchange manifold, the GE Healthcare Compact Block, and the GE Healthcare Compact Block II (later Compact Block). The Multi Absorber should only be used with air, oxygen, nitrous oxide, halothane, enflurane, isoflurane, desflurane and sevoflurane. The device is intended to be used under constant attention of qualified professional healthcare personnel.

Reason for Recall

GE Healthcare has recently become aware of a potential safety issue due to air leakage associated with the CO2 Multi Absorber.

Details

Recalling Firm
GE Healthcare, LLC
Units Affected
US: 59,721 boxes, 358,326 canisters; OUS: 3,724 boxes, 22,344 canisters
Distribution
Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada, Costa Rica, Mexico, and Venezuela.
Location
Waukesha, WI

Frequently Asked Questions

What product was recalled?
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 Breathing System (later ABS), the GE Healthcare EZchange manifold, the GE Healthcare Compact Block, and the GE Healthcare Compact Block II (later Compact Block). The Multi Absorber should only be used with air, oxygen, nitrous oxide, halothane, enflurane, isoflurane, desflurane and sevoflurane. The device is intended to be used under constant attention of qualified professional healthcare personnel.. Recalled by GE Healthcare, LLC. Units affected: US: 59,721 boxes, 358,326 canisters; OUS: 3,724 boxes, 22,344 canisters.
Why was this product recalled?
GE Healthcare has recently become aware of a potential safety issue due to air leakage associated with the CO2 Multi Absorber.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 25, 2013. Severity: Critical. Recall number: Z-0472-2014.