Recall Z-0472-2014 ยท BSF Absorber, Carbon-Dioxide
GE Healthcare, LLC
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 Compa
| Date | Dec 13, 2013 (initiated Sep 19, 2013) |
| Status | Terminated |
| Reason | GE Healthcare has recently become aware of a potential safety issue due to air leakage associated with the CO2 Multi Absorber. |
| Root cause | Device Design |
| Action | GE issued an Urgent Medical Device Correction letter dated September 19, 2013, to all affected customers via Fed Ex overnight mail. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to not use the affected product, isolate all affected product and return the attached form via fax to 800-535-7923. Once the information is received, customers would be contacted with an RMA and replacement information. If product was distributed further the notice should be forwarded to those customers. For questions customers should call 1- |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.