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.
FDA Recall Z-1967-2021 · Posted None
Advertisement
Recalling FirmSpes Medica
Recall StatusTerminated
Product CodeETN
Date Initiated2021-04-08
Date Terminated2022-05-10
Product Quantity20 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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement