FDA Medical Device Recalls (openFDA)
EITAN MEDICAL LTD: Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)
- Recall number
- Z-0094-2024
- 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)
- Status
- Open, Classified
- Initiated
- 2023-09-11
- Posted
- 2023-10-20
- Terminated
- not on file
- Reason
- Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism.
- 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 compliance@eitanmedical.com To report adverse events or product complaints, contact Global Complaint Management, complaints@eitanmedical.com If additional information or technical assistance, contact Customer Service and Technical Assistance, customerservice@eitanmedical.com 1-877-541-9944
- Quantity
- 1383
- Distribution
- US nationwide distribution.
- Lot, serial or model codes
- Software Revision: 16.10.1 or 16.10.2 REF/UDI-DI: 15031-000-0028/7290109150109, 15032-000-0027/7290109150147, 15038-000-0001/7290109150161
- 510(k) numbers
- ["K192860"]
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 3010293992
- Firm city
- Netanya
- Firm state
- not on file
- Firm country
- Israel
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28