FDA recall Z-1968-2021

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

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2021-04-08

Report date

2021-07-07

Termination date

2022-05-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Genoa, N/A, Italy

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1968-2021