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U.S. Department of Health and Human Services

Class 1 Device Recall Sapphire MT Infusion Pump, Sapphire Epidural Infusion Pump, SapphirePlus

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  Class 1 Device Recall Sapphire MT Infusion Pump, Sapphire Epidural Infusion Pump, SapphirePlus see related information
Date Initiated by Firm September 11, 2023
Date Posted October 20, 2023
Recall Status1 Open3, Classified
Recall Number Z-0094-2024
Recall Event ID 93105
510(K)Number K192860  
Product Classification Pump, infusion - Product Code FRN
Product Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)
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
Recalling Firm/
Manufacturer		 EITAN MEDICAL LTD
29, Yad Kharutsim
Netanya Israel
For Additional Information Contact
972.73.2388888
Manufacturer Reason
for Recall		 Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism.
FDA Determined
Cause 2		 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 in Commerce 1383
Distribution US nationwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = Q Core Medical Ltd.
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