FDA-Device2018-03-21Class II
INFINITY DUAL HEMO MCable Pod
Draegar Medical Systems, Inc.
Hazard
Dual Hemo MCable Pods with Revision Index (RI) 15 and 16, which are used with the Dr¿ger Infinity Acute Care System, may permit liquid ingress inconsistent with their IPX4 rating, which could potentially result in an incorrect measured value of invasive blood pressure.
Sold states
Nationally
Affected count
2,760
Manufactured in
6 Tech Dr, Andover, MA, United States
Products
INFINITY DUAL HEMO MCable Pod
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0942-2018Don'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