Date Initiated by Firm |
April 08, 2021 |
Create Date |
June 25, 2021 |
Recall Status1 |
Terminated 3 on May 10, 2022 |
Recall Number |
Z-1970-2021 |
Recall Event ID |
87999 |
510(K)Number |
K113771
|
Product Classification |
Cystometric gas (carbon-dioxide) on hydraulic device - Product Code FAP
|
Product |
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 |
Code Information |
Lot UR20F2699I |
Recalling Firm/ Manufacturer |
Spes Medica Via Buccari 21 Genoa Italy
|
Manufacturer Reason for Recall |
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
|
FDA Determined Cause 2 |
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 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 |
Quantity in Commerce |
30 boxes |
Distribution |
Distribution in the following US states: CA, MA, and SC. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = FAP and Original Applicant = NEUROVISION MEDICAL PRODUCTS, INC.
|