Z-0094-2024 Class I Ongoing
FDA device recall Z-0094-2024 was initiated by EITAN MEDICAL LTD on September 11, 2023 and is designated Class I. Reason for recall: Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism. The recall status is ongoing. Affected quantity: 1383.
Recall Details
- Product Type
- Devices
- Report Date
- October 25, 2023
- Initiation Date
- September 11, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1383
Product Description
Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)
Reason for Recall
Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism.
Distribution Pattern
US nationwide distribution.
Code Information
Software Revision: 16.10.1 or 16.10.2 REF/UDI-DI: 15031-000-0028/7290109150109, 15032-000-0027/7290109150147, 15038-000-0001/7290109150161