Sapphire Infusion Pumps, Models: Multi-Therapy (REF… recallZ-0094-2024 · Eitan Medical Ltd · initiated Sep 11, 2023
Class I Open, Classified All recalls posted in October 2023
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Eitan Medical Ltd or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism.
FDA root cause category: Software Design Change
What the company is doing
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
Recall details
- Recall number
- Z-0094-2024
- Recall class
- Class I (most serious)
- Status
- Open, Classified
- Initiated by the company
- Sep 11, 2023
- Posted by the FDA
- Oct 20, 2023
- Recalling firm
- Eitan Medical Ltd
- Quantity
- 1383
- Product code
- FRN
- FDA submissions
- K192860
- Distribution
- US nationwide distribution.
Product description
Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)
Code information (models, lots, serial numbers)
Software Revision: 16.10.1 or 16.10.2 REF/UDI-DI: 15031-000-0028/7290109150109, 15032-000-0027/7290109150147, 15038-000-0001/7290109150161
Other devices under the same FDA submission
3 devices cleared under K192860 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- AP504-01- UV RESISTANT INFUSION SET WITH VENTED / NON-VENTED DRIP CHAMBER, ROLLE 12000-000-0045Eitan Medical Ltd · Set, Administration, Intravascular1 report
- Sapphire Connect Power Supply 15072-121-1055Eitan Medical Ltd · Accessories, Pump, Infusion1 report
- AP240-01 MICROBORE INFUSION SET WITH NON-VENTED SPIKE, FX ADMINISTRATION CASSETT 12003-000-0069Eitan Medical Ltd · Set, Administration, Intravascular1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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