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Spes Medica recalls SNS Disposable Urethral Catheter Electrode, 10 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhes
Recalled July 7, 2021 · FDA recall Z-1968-2021 · Spes Medica
Hazard
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization. · FDA Class II
Units
34 boxes
Sold at
Distribution in the following US states: CA, MA, and SC.
Description
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
Product
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
Manufacturer(s)
Spes Medica
Made in
Italy
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →