Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF
Summary
The FDA issued a Class I for Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (R by EITAN MEDICAL LTD. Reason: Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism..
Details
Source
Device Recall
External ID
Z-0094-2024
Action Date
2023-10-25
Status
Ongoing
Category
device
Product Description
Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)
Lot/Code Info: Software Revision: 16.10.1 or 16.10.2 REF/UDI-DI: 15031-000-0028/7290109150109, 15032-000-0027/7290109150147, 15038-000-0001/7290109150161
Quantity Affected: 1383
Reason for Recall
Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism.
Distribution
US nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-09-11
Company
Netanya, N/A
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 141 device recalls issued in the same week, part of 403 device-related FDA actions this month.
EITAN MEDICAL LTD has 2 FDA actions in our database, including 1 recall and 1 clearance.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (EITAN MEDICAL LTD) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does EITAN MEDICAL LTD have FDA actions?
EITAN MEDICAL LTD has 2 FDA actions in our database, including 1 recall and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0094-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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