Agency classClass IIOur severity:Severe FDA (Devices)·Z-1511-2019·Announced 2019-06-05

Maquet Getinge-BEQ-TOP Circulatory Circuits Recalled for Sterility Assurance Concerns

Maquet Cardiovascular is recalling specific batches of Maquet Getinge-BEQ-TOP 15704 Circulatory Circuits because a design feature may prevent proper sterilization of 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a failure to assure sterility in a medical device used for extracorporeal circulation, which carries a significant risk of serious injury or infection.

Plain-English summary

Maquet Cardiovascular, LLC is recalling specific batches of Maquet Getinge-BEQ-TOP 15704 Circulatory Circuits 3/8" (Material: 701050859). The affected products are identified by the following batch numbers: 3000047911, 3000054555, 3000062794, 3000071204, 3000072306, and 3000076555. The recall is classified as Class II by the U.S. Food and Drug Administration.

The recall is being issued 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 the sterilization process. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, which poses a potential risk of infection if the product is used.

These products were distributed nationwide. Healthcare facilities and users should stop using the affected circulatory circuits and contact Maquet Cardiovascular for instructions on how to return the products. No specific dates or quantities are provided in the source text.

The recalled product

Product: Maquet Getinge-BEQ-TOP 15704 Circulatory Circuit 3/8" Material: 701050859
Manufacturer: Maquet Cardiovascular, LLC
Category: Medical Device — Cardiovascular
Hazard: infection
sterility-failure

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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