Device 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.
Z-0472-2014
Product summary
- Event
- Event 66638
- Status
- Terminated
- Classification
- Class I
- Quantity
- US: 59,721 boxes, 358,326 canisters; OUS: 3,724 boxes, 22,344 canisters
- Official record key
device-enforcement:Z-0472-2014
Official wording
Reason: GE Healthcare has recently become aware of a potential safety issue due to air leakage associated with the CO2 Multi Absorber.
Code information: product number M1173310 containing lot numbers 12001 through 13031.
Distribution pattern: Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada, Costa Rica, Mexico, and Venezuela.
Derived failure modes
-
Unknown
GE Healthcare has recently become aware of a potential safety issue due to air leakage associated with the CO2 Multi Absorber.