Agency classClass IIOur severity:High FDA (Devices)·Z-1518-2019·Announced 2019-06-05

Maquet Getinge Tubing Sets Recalled Due to Sterility Assurance Concerns

Maquet Cardiovascular is recalling specific 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 involves a medical device where the sterility assurance level cannot be guaranteed, creating a risk of infection. This fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Maquet Cardiovascular, LLC is recalling specific batches of Maquet Getinge-BEQ-TOP 1601#QUADROX iD tubing sets used for extracorporeal circulation. The recall is due to a potential issue with the closed stopcock and non-vented cap configuration. This design may prevent the flow of humidity and ethylene oxide gas into the fluid path during the sterilization process, meaning the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured.

The affected products are identified by the following batch numbers: 3000048235, 3000056129, 3000059730, 3000065496, 3000070700, and 3000073428. The distribution pattern for these products is nationwide.

Healthcare providers and facilities should check their inventory for these specific batch numbers and stop using the affected tubing sets. Users should contact Maquet Cardiovascular, LLC for further instructions on how to handle the recalled products.

The recalled product

Product: Maquet Getinge-BEQ-TOP 1601#QUADROX iD - Pack Material:701052285
Manufacturer: Maquet Cardiovascular, LLC
Category: Medical Device — Cardiovascular / Extracorporeal Circulation
Hazard: sterility-failure
infection-risk

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

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Same hazard · sterility failure