Health product recall

Sapphire Infusion Pump

Last updated

Summary

Product
Sapphire Infusion Pump
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected Products

Lot or serial number

Model or catalog number

Sapphire Epidural

Software16.10.1

15032-000-0001

Sapphire™ Multi-Therapy

Software 16.10.2

15031-000-0032

Issue

Due to a software issue, Sapphire Infusion Pump with SW Version 16.10.1 and 16.10.2 may sometimes fail to identify air in line (AIL). AIL may lead to air embolism. No complaints or patient harm has been reported due to this issue.

Recall start Date: September 22, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
Companies

Eitan Medical Ltd.

29 Yad Haruzim St., Netanya, Israel, 4250529

Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Identification number
RA-74340

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