Agency classClass IIOur severity:High FDA (Devices)·Z-1500-2019·Announced 2019-06-05

Maquet Getinge Extracorporeal Circulation Tubing Sets Recalled for Sterility Assurance Concerns

Maquet Cardiovascular is recalling specific batches of Getinge-BEQ-T 8803#Circ Circuit Small Patient tubing sets because the sterilization process may not ensure sterility in the stopcock ports.

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-T 8803#Circ Circuit Small Patient tubing sets (Material: 701048539) used for extracorporeal circulation. The recall affects specific batch numbers: 3000043059, 3000051269, 3000067520, 3000072508, and 3000080853. The product was 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 between the closed port and the cap during sterilization. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured.

Healthcare facilities and users of these specific tubing sets should stop using the affected batches and contact Maquet Cardiovascular, LLC for further instructions on replacement or return.

The recalled product

Product: Maquet Getinge-BEQ-T 8803#Circ Circuit Small Patient Material: 701048539
Manufacturer: Maquet Cardiovascular, LLC
Category: Medical Device — Cardiovascular / Extracorporeal Circulation
Hazard: sterility-assurance
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 →

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Same hazard · sterility assurance