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Device recall: Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile R

FDA enforcement event 84352 · Class II · initiated 13 Nov 2019 · status Ongoing

DeviceVoluntary: Firm initiated1 product recordWAYNE, NJ

FDA enforcement event 84352 is a device recall by GETINGE US SALES LLC of WAYNE, NJ, initiated 13 Nov 2019 and classified Class II, with 1 product record.

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. 88% of the 968 device enforcement events initiated in 2019 carry the same class.

Status: Ongoing. Initiation: voluntary: firm initiated. GETINGE US SALES LLC has 9 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

GETINGE US SALES LLC, WAYNE, NJ.

Reason for recall

"Sterile barrier system may be compromised"

Distribution

"Nationwide Canada"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0677-2020	Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile REF: BEQ-HMOD 30000	3633 US	Class II	Ongoing	18 Dec 2019

Context

88%of 2019 device events are Class II968 events that year

1product record in this eventfirm median: 1

9events on this register for the firm

Other enforcement events for GETINGE US SALES LLC

Initiated	Product (first record)	Type	Class	Records
22 Aug 2019	The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a woven double velour polyester graft impregnated with hig	Device	Class II	1
22 Jul 2019	Getinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems.	Device	Class II	1
5 Jun 2019	PulsioFlex Monitoring System, Part Number: 6882747, Model Number: PC400 3 R0. Usage: The PulsioFlex Monitoring System is	Device	Class II	1
20 Mar 2019	Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg Product Code/REF Number: 6685775 Product Usage: T	Device	Class III	1
8 Jan 2019	Maquet XS Flat Screen Monitor Holder, XS32 SPE, Configuration Part Number ARD22201040A Product Usage: This product is de	Device	Class II	4
7 Feb 2018	VOLISTA StandOP Surgical Light; Model numbers VLT600 SF AIM STP, VLT600 DF AIM STP, Ref. codes ARD568811901, ARD56881191	Device	Class II	1
3 Jan 2018	HEMASHIELD Knitted Double Velour Cardiovascular Fabric	Device	Class II	1
16 Nov 2017	ALM XTEN Surgical Light intended to provide visible illumination for the surgical field or for the examination of the pa	Device	Class II	1

All 9 events for GETINGE US SALES LLC

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Sterile barrier system may be compromised"

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: "Nationwide Canada"

Is the recall still ongoing?

FDA lists the status as Ongoing. "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.