Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator Recalled by GETINGE US SALES LLC Due to Sterile barrier system may be compromised

Date: November 13, 2019
Company: GETINGE US SALES LLC
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact GETINGE US SALES LLC directly.

Affected Products

Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile REF: BEQ-HMOD 30000

Quantity: 3633 US

Why Was This Recalled?

Sterile barrier system may be compromised

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About GETINGE US SALES LLC

GETINGE US SALES LLC has 12 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report