CLASS II Device recall · Reported 21 Mar 2018 · FDA Enforcement Report

Infinity Dual Hemo MCable Pod recalled by Draegar Medical Systems

Draegar Medical Systems is recalling Infinity Dual Hemo MCable Pod, distributed nationwide in the US. The recall was initiated on 4 Oct 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesHave the affected revision indexes: 15 or 16 (found on the product label)

Quantity recalled2,760

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0942-2018
FDA event ID: 79209
Recalling firm: Draegar Medical Systems, Andover, MA
Classification: Class II
Status: Terminated
Recall initiated: 4 Oct 2017
FDA classified: 9 Mar 2018
Reported: 21 Mar 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

4 Oct 2017	Recall initiated by company
9 Mar 2018	Classified by FDA	+156 days
21 Mar 2018	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

INFINITY DUAL HEMO MCable Pod

Where it was distributed

Nationally

Nationwide

Questions about this recall

Is Infinity Dual Hemo MCable Pod recalled?

Yes. Draegar Medical Systems recalled Infinity Dual Hemo MCable Pod on 4 Oct 2017. The recall is Class II and its status is Terminated. Recall number Z-0942-2018.

Why was it recalled?

Which lots are affected?

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

Where was it sold?

Nationally

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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