FDA-Device2014-08-20Class II
X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product Number 800541
Gambro Renal Products, Incorporated
Hazard
Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
Sold states
Worldwide Distribution.
Affected count
401,451
Manufactured in
14143 Denver West Pkwy, N/A, Lakewood, CO, United States
Products
X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product Number 800541
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2207-2014Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief