Olympus Corporation of the Americas Recall 93792
Description: Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used with Olympus endoscope reprocessor for prevent contamination of the rinse water. The MAJ-2318 water filter is compatible with OER-ELITE and OER-MINI.
Olympus Corporation of the Americas Recall 93792 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1009-2024 |
| Event ID | 93792 |
| Event Description | Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used with Olympus endoscope reprocessor for prevent contamination of the rinse water. The MAJ-2318 water filter is compatible with OER-ELITE and OER-MINI. |
| Product Type | Devices |
| Distribution | Domestic US distribution nationwide. |
| Quantity | 877 MAJ-2318, 119 OER-Elite, 3 OER-MINI |
| Recall Reason | Water filter may have been assembled incorrectly, resulting in unfiltered tap water being used for reprocessing. This may expose a patient to a potentially contaminated device, presenting a risk of infection or sepsis. |
| Device Classification | 20240214 |
| Device Code Info | UDI-DI 04953170401473 Lots 36A, 37A, 38A Affected product may have also been packaged within OER boxes (OER-Elite and OER-MINI) |
| Center Classification Date | 20240207 |
| Recall Initiation Date | 20240116 |
| Recalling Firm | Olympus Corporation of the Americas |
| Initial Notification | Letter |
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