Genoa, N/A, Italy
Spes Medica recalls
1 recall recorded since 2018, most recently on 8 April 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 8 April 2021
- Terminated
- 10 May 2022
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1968-2021, Z-1967-2021, Z-1971-2021, Z-1970-2021, Z-1969-2021
- 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
- Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 7.5-10.0, Channel 1, Reference Numbers LSE4246MCA075 and LSE500M. for continuous EMG monitoring of the larynx during surgical procedures.
- Tripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D. Used during intraoperative neurological monitoring.
- SNS Disposable Urethral Catheter Electrode, 14 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesive with attached 2 meter lead-wire with touch-proof connector, Reference Number UE002
- Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 6.0-7.5, Channel 2, Reference Number LSE3463DCA200 and LSE500DCS-5. for continuous EMG monitoring of the larynx during surgical procedures.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.