Draegar Medical Systems, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0942-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

INFINITY DUAL HEMO MCable Pod

Product Classification:

Class II

Date Initiated: October 4, 2017

Date Posted: March 21, 2018

Recall Number: Z-0942-2018

Event ID: 79209

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.

Status: Terminated

Product Quantity: 2,760

Code Information:

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

Distribution Pattern:

Nationally

Voluntary or Mandated:

Voluntary: Firm initiated