Agency classClass IIOur severity:High FDA (Devices)·Z-1619-2019·Announced 2019-06-05

Maquet Cardiovascular Recalls Custom Tubing Sets for Extracorporeal Circulation

Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design flaw may prevent sterilization gas from reaching all parts of the device.

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 (potential lack of sterility in a medical device) where injury has not yet been reported, which aligns with the 'High' severity criteria.

Plain-English summary

Maquet Cardiovascular, LLC is recalling Custom Tubing Sets for Extracorporeal Circulation (ECC). The affected product is identified as Maquet Getinge-BEQ-T 9409 Lurie Chlds Large 3/8, Material 709000428. The recall covers specific batch numbers: 3000061513, 3000071803, 3000075279, and 3000077546. The products 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 fully sterile.

Healthcare facilities and users of these devices should stop using the affected tubing sets and contact Maquet Cardiovascular, LLC for instructions on return or replacement. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product: Maquet Getinge-BEQ-T 9409 Lurie Chlds Large 3/8 Material: 709000428
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: 3000061513 3000071803 3000075279 3000077546

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