Recall Z-0472-2014— GE Healthcare, LLC

Class I FDA medical device recall by GE Healthcare, LLC, initiated 2013-09-19, terminated 2015-03-10. FDA's recall record names no specific 510(k) clearance for this event. 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 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: GE Healthcare has recently become aware of a potential safety issue due to air leakage associated with the CO2 Multi Absorber..

Recalling firm

GE Healthcare, LLC

Classification

Class I

Status

Terminated

Initiated

2013-09-19

Terminated

2015-03-10

Firm location

Waukesha, WI, United States

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