Agency classClass IIOur severity:High FDA (Devices)·Z-1629-2019·Announced 2019-06-05

Maquet Getinge ECC Tubing Sets Recalled Due to Sterility Assurance Concerns

Maquet Cardiovascular is recalling specific ECC tubing sets because a design feature may prevent proper sterilization, potentially compromising sterility.

The agency’s classification

FDA (Devices): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (sterility failure) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical hazards without confirmed illness.

Plain-English summary

Maquet Cardiovascular, LLC is recalling Maquet Getinge-BEQ-TOP 8013 ECC QUADROX iD Pack RF32 Custom Tubing Sets for Extracorporeal Circulation. The recall affects units with Batch Number 3000078425, which were distributed nationwide.

The recall was initiated because the closed stopcock and non-vented cap configuration may prevent the flow of humidity and ethylene oxide gas into the fluid path during sterilization. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, meaning the devices may not be sterile.

Healthcare facilities should stop using the affected tubing sets and contact Maquet Cardiovascular for instructions on return or replacement. Consumers are not directly affected as these are medical devices used in clinical settings.

The recalled product

Product: Maquet Getinge-BEQ-TOP 8013 ECC QUADROX iD Pack RF32 Material:701047962R01
Manufacturer: Maquet Cardiovascular, LLC
Category: Medical Device — Cardiovascular
Hazard: sterility-failure
infection-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

Batch Numbers: 3000078425

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 183 recalled by Maquet Cardiovascular, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 183 products in this recall →

Same manufacturer · Maquet Cardiovascular, LLC

See all →

High
Vasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22
High
Vessel harvesting systems recalled after out-of-box failures in harvesting tool jaws
FDA (Devices) · 2025-10-01
High
Heartstring III seal systems recalled over failures to load, deploy and seal
FDA (Devices) · 2025-09-24
High
Heartstring III 4.3 mm seal systems recalled over loading and deployment failures
FDA (Devices) · 2025-09-24
High
Heartstring III 3.8 mm seal systems recalled over three identified failure modes
FDA (Devices) · 2025-09-24

Same hazard · sterility failure