Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 1 Device Recall Sapphire MT Infusion Pump, Sapphire Epidural Infusion Pump, SapphirePlussee related information
Date Initiated by FirmSeptember 11, 2023
Date PostedOctober 20, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0094-2024
Recall Event ID 93105
510(K)NumberK192860 
Product Classification Pump, infusion - Product Code FRN
ProductSapphire 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
ActionOn 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 Commerce1383
DistributionUS nationwide distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FRN
-
-