Recall Z-1967-2021 ยท ETN Stimulator, Nerve
Spes Medica
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.
| Date | Apr 8, 2021 |
| Status | Terminated |
| Reason | The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization. |
| Root cause | Material/Component Contamination |
| Action | An email titled "Object: Spes Medica Safety Notice for possible Non-Conformities to Steril Milano" dated 4/8/21 was sent to customers. Following the communications of Steril Milano and the Ministry of Health (http:ljwww.salute.gov.it/portale/news/p3 2 1 1 1.jsp ?lingua=italiano&menu=notizie&p=dalministero&id=5365) on possible deviations of the parameters/processes defined for ethylene oxide sterilization, already validated and routinely used by Steril Milano; the company Spes Medica S.r.I. informs you that in the years 2019-2020-2021 has used the Steril Milano supplier only once in- August |
| Quantity | 20 boxes |
| Distribution | Distribution in the following US states: CA, MA, and SC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093373 | LARYNGEAL SURFACE ELECTRODE Spes Medica Srl, Aug 24, 2010 |