Recall Z-0942-2018— Draegar Medical Systems, Inc.

Name: FDA recall Z-0942-2018
Creator: U.S. Food and Drug Administration
Published: 2017-10-04

Class II · Terminated

Class II FDA medical device recall by Draegar Medical Systems, Inc., initiated 2017-10-04, terminated 2018-06-15. It names one FDA 510(k) clearance: K113798. Product: INFINITY DUAL HEMO MCable Pod. 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..

Recalling firm: Draegar Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-10-04
Terminated: 2018-06-15
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K113798 — INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SETDraeger Medical Systems, Inc.·cleared 2012-03-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.