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
Recall
- Recall Number
- Z-1970-2021
- Event Number
- 87999
- Firm
- Spes Medica Via Buccari
- FEI Number
- 3011534533
- Product Code
- FAP
- Status
- Terminated
- Root Cause
- Material/Component Contamination
- Initiated
- April 8, 2021
- Terminated
- May 10, 2022
- Address
- 21 Genoa Italy
Description
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
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
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
Distribution in the following US states: CA, MA, and SC.
30 boxes