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U.S. Department of Health and Human Services

Enforcement Report - Week of December 26, 2013

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Event Detail

Event ID 66638
Product Type Devices
Status Ongoing
Recalling Firm GE Healthcare, LLC
City Waukesha
State WI
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-09-19
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada, Costa Rica, Mexico, and Venezuela.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Multi Absorber Original, Disposable M1173310 Multi Absorber Original, Disposable, package of 6 pcs, GE Healthcare Finland Oy Kuortaneenkatu 2 FI-00510 Helsinki, Finland +358 10 394 11 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. Product number M1173310 containing lot numbers 12001 through 13031. Class I GE Healthcare has recently become aware of a potential safety issue due to air leakage associated with the CO2 Multi Absorber. US: 59,721 boxes, 358,326 canisters; OUS: 3,724 boxes, 22,344 canisters Z-0472-2014
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