Recall Z-1385-2019 ยท LGZ Warmer, Thermal, Infusion Fluid
Vyaire Medical
enFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood solutions.
| Date | Jun 26, 2019 (initiated Mar 13, 2019) |
| Status | Terminated |
| Reason | Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming. |
| Root cause | Device Design |
| Action | 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 |
| Quantity | 5,782,820 units total |
| 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, Uni |
| FDA record | Open on fda.gov |