Source

SFDA- Saudi Food & Drug Authority.

https://ade.sfda.gov.sa/Fsca/PublishDetails/234

Product

EOPA™ Elongated One-Piece Arterial Cannula.

Manufacturer

Medtronic, Inc.

Local agent

AL Zahrawi Medical Supplies

The affected products

Product Description: EOPA™ Arterial Cannula

Model Number: 77418.

Lot Number : 2022041038.

Correct Labelling: Box should be: 77418, Pouch should be: 77418, Cannula should be: 18 Fr.

Discrepancy: Cannula might be: 22 Fr.

Reason

Products for the models listed above were incorrectly labelled with an incorrect size.

Action

1. Immediately identify and quarantine all unused, listed product in your inventory.

2. Return unused, listed product in your inventory to Medtronic.

3. Contact the local agent for remedial action.

comments

Healthcare professionals are encouraged to report any adverse events Suspected to be associated with the above device or any other medical device to Department of Medical Device Control through the E-mail: vigilance-md@moh.gov.om