Recall record at a glance
| Official record | Z-0472-2014 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class I |
| FDA record status | Terminated |
| Recalling firm | GE Healthcare, LLC |
| Report date | Dec 25, 2013 |
| Recall initiation date | Sep 19, 2013 |
| Quantity | US: 59,721 boxes, 358,326 canisters; OUS: 3,724 boxes, 22,344 canisters |
| Location | Waukesha, WI, United States |
Official 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.
Why the product was recalled
GE Healthcare has recently become aware of a potential safety issue due to air leakage associated with the CO2 Multi Absorber.
Distribution information
Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada, Costa Rica, Mexico, and Venezuela.
How to read the classification
FDA Class I indicates a situation in which there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. The classification shown here comes directly from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.