FDA Device recall Z-1970-2021
SNS Disposable Urethral Catheter Electrode, 14 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesive with attached 2…
- FDA Device
- Class II
- terminated
- Published 2021-07-07
On 2021-07-07 the FDA classified a Class II recall of SNS Disposable Urethral Catheter Electrode, 14 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesive with attached 2… by Spes Medica, citing the supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1970-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-04-08 |
| Published | 2021-07-07 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Spes Medica |
| Distribution | CA, MA, SC |
Product
SNS Disposable Urethral Catheter Electrode, 14 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesive with attached 2 meter lead-wire with touch-proof connector, Reference Number UE002
Reason
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
Identifiers
| code_info | Lot UR20F2699I |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1970-2021%22
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