Agency classClass IIOur severity:High FDA (Devices)·Z-1550-2019·Announced 2019-06-05

Maquet Getinge Neonatal Tubing Sets Recalled for Sterility Assurance Concerns

Maquet Cardiovascular is recalling specific neonatal tubing sets because a design feature may prevent sterilization gas from reaching all parts, 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 assured, creating a risk of infection. This fits the 'High' severity criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Maquet Cardiovascular, LLC is recalling Maquet Getinge-BEQ-TOP 2202 NEONATAL SPECIALT Custom Tubing Sets for Extracorporeal Circulation (ECC). The recall involves specific batch numbers 3000041407 and 3000069806, which were distributed nationwide.

The recall is due to a potential issue with the closed stopcock/non-vented cap configuration. During the sterilization process, this configuration may prevent the flow of humidity and ethylene oxide gas into the fluid path between the closed port and the non-vented cap. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, meaning the sterility of these specific components is not guaranteed.

Healthcare facilities and users of these products should stop using the affected tubing sets and contact Maquet Cardiovascular for further instructions on how to proceed.

The recalled product

Product: Maquet Getinge-BEQ-TOP 2202 NEONATAL SPECIALT Material:701062613
Manufacturer: Maquet Cardiovascular, LLC
Category: Medical Device — Cardiovascular / Extracorporeal Circulation
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: 3000041407 3000069806

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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Same hazard · sterility failure