Agency classClass IIOur severity:High FDA (Devices)·Z-1534-2019·Announced 2019-06-05

Maquet Getinge AV Loop Tubing Recalled Due to Sterility Assurance Concerns

Maquet Cardiovascular is recalling specific AV Loop tubing sets because a design feature 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 medical device where sterility cannot be assured, posing a risk of infection (risk-of-harm product) without reported injuries, which aligns with the 'High' severity criteria.

Plain-English summary

Maquet Cardiovascular, LLC is recalling Maquet Getinge-BEQ-TOP 21503 ECC 1/4" AV LOOP tubing sets. The recall affects specific batch numbers: 3000043295, 3000047248, 3000047254, 3000055638, 3000062271, 3000065551, 3000069074, and 3000075386. 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 during sterilization. This issue means the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, potentially leaving the device non-sterile.

Healthcare facilities and users should check their inventory for the affected batch numbers. If the product is found, it should be removed from use and returned to the manufacturer or the appropriate regulatory authority as directed.

The recalled product

Product: Maquet Getinge-BEQ-TOP 21503 ECC 1/4" AV LOOP Material:701054776
Manufacturer: Maquet Cardiovascular, LLC
Category: Medical Device — Cardiovascular / Extracorporeal Circulation
Hazard: sterility-failure
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 →

Same manufacturer · Maquet Cardiovascular, LLC

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Same hazard · sterility failure