Agency classClass IIOur severity:High FDA (Devices)·Z-1525-2019·Announced 2019-06-05

Maquet Getinge ECC Tubing Sets Recalled Due to Sterility Assurance Concerns

Maquet Cardiovascular is recalling specific batches of Custom Tubing Sets for Extracorporeal Circulation 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 is classified as FDA Class II and involves a risk of harm (infection due to non-sterile medical devices) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Maquet Cardiovascular, LLC is recalling specific batches of Custom Tubing Sets for Extracorporeal Circulation (ECC), identified by the product name Maquet Getinge-BEQ-T 8805 ECC PACK and material number 701053361. The affected batch numbers are 3000071966, 3000074121, 3000075280, and 3000077082. The recall is classified as Class II by the U.S. Food and Drug Administration.

The recall was initiated because the closed stopcock and non-vented cap configuration of the tubing sets may prevent the flow of humidity and ethylene oxide gas into the fluid path during the sterilization process. This potential blockage means that the Sterility Assurance Level (SAL) for the stopcock ports cannot be assured, creating a risk that the devices may not be sterile when used.

The affected products were distributed nationwide. Healthcare facilities and users of these specific tubing sets should stop using the affected batches and contact Maquet Cardiovascular for further instructions on how to return or replace the products.

The recalled product

Product: Maquet Getinge-BEQ-T 8805 ECC PACK Material: 701053361
Manufacturer: Maquet Cardiovascular, LLC
Category: Medical Device — Surgical Tubing
Hazard: infection
sterility-failure

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: 3000071966 3000074121 3000075280 3000077082

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 →

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