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Terminated

Tripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D. Used during intraoperative neurological monitoring.

FDA Recall Z-1971-2021 · Posted None

Recalling FirmSpes Medica
Recall StatusTerminated
Product CodeETN
Date Initiated2021-04-08
Date Terminated2022-05-10
Product Quantity3 boxes

Reason for Recall

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

Firm 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 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: [email protected] Telephone number: +39 010 80 667 67

Root Cause

Material/Component Contamination

Distribution Pattern

Distribution in the following US states: CA, MA, and SC.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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