Z-0942-2018Class II

INFINITY DUAL HEMO MCable Pod

Name: Z-0942-2018 INFINITY DUAL HEMO MCable Pod
Creator: Draegar Medical Systems, Inc.
Published: 2017-10-04
License: https://open.fda.gov/license/

Draeger Medical Systems, Inc. / initiated 2017-10-04 / Terminated / root cause: manufacturing process

FDA source

Draegar Medical Systems, Inc. began a recall of INFINITY DUAL HEMO MCable Pod on 2017-10-04. FDA classified it as Class II and gives the reason as "Dual Hemo MCable Pods with Revision Index (RI) 15 and 16, which are used with the Drger Infinity Acute Care System, may permit liquid ingress inconsistent with their IPX4 rating, which could potentially result in an...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0942-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-04
Posted: 2018-03-09
Terminated: 2018-06-15
Recalling firm: Draeger Medical Systems, Inc.
Product: INFINITY DUAL HEMO MCable Pod
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: Dual Hemo MCable Pods with Revision Index (RI) 15 and 16, which are used with the Drger 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: In September of 2017 an Urgent medical Device Recall letter was issued to customers informing them of the recall and to request that inventory be checked to see if the product subject in the recall is on the premises. To do this, the customer will check the label for the revision index number which is located on the upper middle portion of label. RI number 15 and 16 are included in the recall. No other numbers are subject to recall. Affected product will receive a sleeve from the company to correct the issue. Questions or concerns can be directed to 1-800-437-2437 (Press 1, then press 32349) or contact Customer Care at 1-800-437-2437 (Press 4, then press 4 again)
Quantity in commerce: 2,760
Distribution: Nationally
Product codes and lots: Have the affected revision indexes: 15 or 16 (found on the product label)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0942-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0942-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-09

Product code MHX

K113798Class IIInfinity Acute Care System, Infinity Mcable- Masimo Rainbow SetDraeger Medical Systems, Inc. / cleared 2012-03-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)