Z-0094-2024Class I

Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and...

Name: Z-0094-2024 Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and...
Creator: Eitan Medical Ltd
Published: 2023-09-11
License: https://open.fda.gov/license/

Eitan Medical Ltd / initiated 2023-09-11 / Open, Classified / root cause: software

FDA source

EITAN MEDICAL LTD began a recall of Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001) on 2023-09-11. FDA classified it as Class I and gives the reason as "Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0094-2024
Classification: Class I
Status: Open, Classified
Initiated: 2023-09-11
Posted: 2023-10-20
Recalling firm: Eitan Medical Ltd
Product: Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)
Product code: FRN Pump, Infusion
Reason for recall: Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism.
Root cause tag: software
FDA root cause: Software Design Change
Action: On 9/11/23, recall notices were emailed to customers informing them of the following: The Affected Pumps may fail to identify air in line when the following conditions are met: 1. The pump is operating on battery power (not connected to a power supply) 2. Treatments are water-like solutions (TPN and other opaque solutions are not affected) Until the Affected Pumps in your facility have been updated with new software, users are advised to only operate the effected devices as follows: i. Connect to continuous AC power during treatment (i.e., connect to a power supply) and/or; ii. Use with air eliminating filters sets: - Available Eitan Medical sets with filters: AP206-01, AP240-01, AP 214-01, AP 204-01, AP223-01, or; - Connect a 3rd party air eliminating filter set extension to the end of the Sapphire set. Alternatively, use software version - Rev15.10. Complete and return the Customer Response form via email to [email protected] To report adverse events or product complaints, contact Global Complaint Management, [email protected] If additional information or technical assistance, contact Customer Service and Technical Assistance, [email protected] 1-877-541-9944
Quantity in commerce: 1383
Distribution: US nationwide distribution.
Product codes and lots: Software Revision: 16.10.1 or 16.10.2 REF/UDI-DI: 15031-000-0028/7290109150109, 15032-000-0027/7290109150147, 15038-000-0001/7290109150161

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0094-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0094-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-10-25	2023-10-19

Product code FRN

K192860Class IISapphire Infusion Pump, Sapphire administration setsQ Core Medical , Ltd. / cleared 2020-11-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)