Agency classClass IIOur severity:High FDA (Devices)·Z-1503-2019·Announced 2019-06-05

Maquet Getinge Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design configuration 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 potential failure to ensure sterility in a medical device used for extracorporeal circulation, which poses a risk of infection. This aligns with the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Maquet Cardiovascular, LLC is recalling Maquet Getinge-BEQ-T-22800 custom tubing sets for extracorporeal circulation (ECC). The recall involves specific batch numbers 3000046489 and 3000055506, which were distributed nationwide.

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

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

The recalled product

Product: Maquet Getinge-BEQ-T-22800 Material: 701049506
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: 3000046489 3000055506

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