Food, drugs, devices › Draegar Medical Systems, Inc.

Device recall: INFINITY DUAL HEMO MCable Pod

FDA enforcement event 79209 · Class II · initiated 4 Oct 2017 · status Terminated · terminated 15 Jun 2018

DeviceVoluntary: Firm initiated1 product recordAndover, MA

Draegar Medical Systems, Inc. (Andover, MA) initiated this device recall on 4 Oct 2017; FDA lists 1 product record under event 79209, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.

Status: Terminated, terminated 15 Jun 2018. Initiation: voluntary: firm initiated. Draegar Medical Systems, Inc. has 10 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Draegar Medical Systems, Inc., Andover, MA.

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."

Distribution

"Nationally"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0942-2018	INFINITY DUAL HEMO MCable Pod	2,760	Class II	Terminated	21 Mar 2018

Context

93%of 2017 device events are Class II1,091 events that year

1product record in this eventfirm median: 1

10events on this register for the firm

Other enforcement events for Draegar Medical Systems, Inc.

Initiated	Product (first record)	Type	Class	Records
4 Mar 2022	Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wir	Device	Class II	1
23 Dec 2020	Infinity Acute Care System (IACS) Monitoring Solution: The IACS is intended for multi-parameter, physiologic patient mon	Device	Class II	1
9 Oct 2019	Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755, MS26076, MS26031,	Device	Class II	1
13 Sep 2019	The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor. Model nos.	Device	Class II	1
8 Feb 2019	Infinity Delta Family patient monitors The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used	Device	Class II	2
28 Mar 2018	Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS20401, MS20724, MS22956, MS25510, MS25520, MS25	Device	Class II	1
21 Feb 2018	Infinity Acute Care System (IACS) Monitoring Solution, Catalog Numbers: MS18841, MS20401, MS20407, MS20724, MS22956, MS2	Device	Class II	1
6 Jun 2017	Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722	Device	Class II	1
28 Mar 2017	Delta, Catalog Number: MS18597 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus. P	Device	Class II	3

All 10 events for Draegar Medical Systems, Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "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."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "Nationally"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 15 Jun 2018. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.