Recall Z-1971-2021
Spes Medica · initiated April 8, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Tripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D. Used during intraoperative neurological monitoring.
Codes / lots: Lot SI20F2956I
Reason for recall
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
FDA-determined cause: Material/Component Contamination
Action taken
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 2020. However only for safety reason If you have the following products in your stock, we ask you to immediately block the sale and the use and, in case, to forward this request to your customers or sub-distributors. Please contact our Customer Service to send back to us the products, we will replace with another LOT number. For any request for clarification or support, do not hesitate to contact: Eng. Giorgio Facco e-mail: guality@spesmedica.com Telephone number: +39 010 80 667 67
Details
- Recall number
- Z-1971-2021
- Initiated
- April 8, 2021
- Terminated
- May 10, 2022
- Product code
- ETN – Stimulator, Nerve
- Quantity
- 3 boxes
- Distribution
- Distribution in the following US states: CA, MA, and SC.
- Recalling firm
- Spes Medica, Genoa
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1967-2021 Class II | Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 7.5-10.0, Channel 1, Reference…The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide… | 04/08/2021Terminated |
| Z-1968-2021 Class II | SNS Disposable Urethral Catheter Electrode, 10 Fr, Gold Recording/Stimulating Contact…The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide… | 04/08/2021Terminated |
| Z-1969-2021 Class II | Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 6.0-7.5, Channel 2, Reference…The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide… | 04/08/2021Terminated |
| Z-1970-2021 Class II | SNS Disposable Urethral Catheter Electrode, 14 Fr, Gold Recording/Stimulating Contact…The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide… | 04/08/2021Terminated |