Written by: Doris McGirt, MedicalSCI, Published April 2019
When it comes to work, it is our company’s Mission Statement, Vision, Purpose and Values that drives us. Maybe I’m using these as an excuse to go against my normal policy of “not throwing stones”, however I would not be true to all that our company stands for if I did not publicly give the information below. I am hoping that those of you who should already have this information do already have it. If not – here it is.
The manufacturer of enFlow® Fluid Warming System, Vyaire Medical, issued on March, 13, 2019 a global recall of their disposable intravenous cartridges (part numbers 980200EU, 980202EU). As all of us know, the disposable IV unit is a crucial part of any intravenous administration system and something you cannot do without.
Their decision was based on testing that indicated the aluminum component of the enFlow® disposable cartridge could leach out into the fluid as it was being administered to patients.
Vyaire Medical is directing all of their worldwide customers to suspend the use of the enFlow® and to follow their instructions provided by the company. They do specify that this recall does not affect their enFlow® Warmer, Controller, and accessories and are advising their customers to “retain these items as Vyaire is exploring the development of a new cartridge, compatible with the current enFlow® system, to minimize aluminum exposure”.
If you are an enFlow® Fluid Warming System user, I hope you have been notified by your local country’s enFlow® office or distributor. If they have not given you this information then please get in touch with your enFlow® contact person as soon as possible. You need to know how to handle this recall.
Here is the link to Vyaire Medical’s “product alert”:
https://www.vyaire.com/news/vyaire-medical-enflow-recall
Please contact me directly if any additional clarification is needed. dmcgirt@medicalsci.com
