Skip to content
Recall Observatory FDA recall evidence

Device product

INFINITY DUAL HEMO MCable Pod

Z-0942-2018

October 04, 2017

Class II

Product summary

Firm
Draegar Medical Systems, Inc.
Event
Event 79209
Status
Terminated
Classification
Class II
Quantity
2,760
Official record key
device-enforcement:Z-0942-2018

Official wording

Reason: 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.

Code information: Have the affected revision indexes: 15 or 16 (found on the product label)

Distribution pattern: Nationally

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.