Public recall detail

Sapphire Infusion Pump

2023-09-27

medium
Recall Safety notice
Quick summary

Quick summary: Sapphire Infusion Pump. Date: 2023-09-27.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Sapphire Infusion Pump. Date: 2023-09-27.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandEitan Medical Ltd
ProductSapphire Infusion Pump
IssueMedical devices - Performance
Recall classType I
IdentificationRA-74340

Affected products

ProductSapphire Epidural
LotSoftware16.10.1
Model15032-000-0001
Serial numberSoftware16.10.1
DescriptionSapphire Epidural
ProductSapphire™ Multi-Therapy
LotSoftware 16.10.2
Model15031-000-0032
Serial numberSoftware 16.10.2
DescriptionSapphire™ Multi-Therapy

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Anaesthesiology
CompaniesEitan Medical Ltd. 29 Yad Haruzim St., Netanya, Israel, 4250529
Published byHealth Canada
Recall classType I
Alert / recall typeHealth product recall
Identification numberRA-74340
Background{}
CompaniesEitan Medical Ltd. 29 Yad Haruzim St., Netanya, Israel, 4250529
AudiencesHealthcare
Source updated2023-09-27

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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