Recall Z-1968-2021— Spes Medica

Name: FDA recall Z-1968-2021
Creator: U.S. Food and Drug Administration
Published: 2021-04-08

Class II · Terminated

Class II FDA medical device recall by Spes Medica, initiated 2021-04-08, terminated 2022-05-10. It names one FDA 510(k) clearance: K113771. 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: The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization..

Recalling firm: Spes Medica
Classification: Class II
Status: Terminated
Initiated: 2021-04-08
Terminated: 2022-05-10
Firm location: Genoa, N/A, Italy

510(k) clearances named in this recall

1 on FDA's record

K113771 — SIGNAL GEAR URETHRAL CATHETER ELECTRODENeurovision Medical Products, Inc.·cleared 2012-12-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product 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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.