Spes Medica Recall 87999
Description: SNS Disposable Urethral Catheter Electrode, 10 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesive with attached 2 meter lead-wire with touch-proof connector, Reference Number UE006
Spes Medica Recall 87999 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1968-2021 |
| Event ID | 87999 |
| Event Description | SNS Disposable Urethral Catheter Electrode, 10 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesive with attached 2 meter lead-wire with touch-proof connector, Reference Number UE006 |
| Product Type | Devices |
| Distribution | Distribution in the following US states: CA, MA, and SC. |
| Quantity | 34 boxes |
| Recall Reason | The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization. |
| Device Classification | 20210707 |
| Device Code Info | Lot UR20F2702I |
| Center Classification Date | 20210625 |
| Recall Initiation Date | 20210408 |
| Recalling Firm | Spes Medica |
| Initial Notification | |
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