FDA recall Z-0942-2018

Product

INFINITY DUAL HEMO MCable Pod

Reason for recall

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.

Distribution

Nationally

Key facts

Status

Terminated

Initiation date

2017-10-04

Report date

2018-03-21

Termination date

2018-06-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0942-2018