enFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood solutions.
This recall has been terminated (originally issued June 26, 2019).
- Company
- Vyaire Medical
- Recall Initiated
- March 13, 2019
- Posted
- June 26, 2019
- Terminated
- September 22, 2020
- Recall Number
- Z-1385-2019
- Quantity
- 5,782,820 units total
- Firm Location
- Mettawa, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming.
Distribution
Worldwide Distribution. US nationwide, Brazil, Canada, Chile, Colombia, Ecuador, Hong Kong, Hungary, Israel, India, Jordan, Korea, Kuwait, Kazakhstan, Lebanon, Macedonia, Mexico, Malaysia , Myanmar, Netherlands, New Zealand, Oman, Peru, Qatar, Russian Federation, Saudi Arabia, Thailand, Turkey, United Republic of Tanzania, South Africa, Panama, and Viet Nam.
Lot / Code Info
Part Number: 980200EU. All units distributed through March 7, 2019.
Root Cause
Device Design
Action Taken
Vyaire Medical notified consignees on about 03/13/2019 via URGENT NOTIFICATION OF RECALL letter. Consignees were instructed to conduct a 100% physical inventory to identify any affected product on hand, destroy all affected product in-stock in accordance with each facility's destruction protocol and if a facility is unable to destroy the product on site, or requires assistance, they were instructed to contact VyaireSupport@stericycle.com or call for assistance. Customers were also instructed to complete and return the Customer Response Form to VyaireSupport@stericycle.com, report any adverse reactions or quality problems to Vyaire's Technical Support Department by e-mail GMB-RS-DISP-Complaint-Intake@carefusion.com or telephone at 1-800-231-2466 prompt #1. If customers further distributed the product, they were instructed to forward a copy of the URGENT NOTIFICATION OF RECALL letter and Response Form to all customers and include the contact information to Vyaire for tracking purposes.