Spes Medica recalls SNS Disposable Urethral Catheter Electrode, 10 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhe…

Recall date

April 8, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1968-2021

FDA classification

Class II

Brand / firm

Spes Medica

Sold / distributed

Distribution in the following US states: CA, MA, and SC.

Why it was recalled

The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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