Spes Medica Recalls
5 recalls on record · July 7, 2021 to July 7, 2021 · Medical Devices
July 7, 2021Medical DevicesFDA
Spes Medica recalls Tripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D. Used during intraoperative neurological mo
Hazard: The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
July 7, 2021Medical DevicesFDA
Spes Medica recalls SNS Disposable Urethral Catheter Electrode, 14 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhes
Hazard: The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
July 7, 2021Medical DevicesFDA
Spes Medica recalls Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 6.0-7.5, Channel 2, Reference Number LSE3463DCA200 and LSE500D
Hazard: The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
July 7, 2021Medical DevicesFDA
Spes Medica recalls SNS Disposable Urethral Catheter Electrode, 10 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhes
Hazard: The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
July 7, 2021Medical DevicesFDA
Spes Medica recalls Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 7.5-10.0, Channel 1, Reference Numbers LSE4246MCA075 and LSE50
Hazard: The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.