Agency classClass IIOur severity:High FDA (Devices)·Z-1657-2019·Announced 2019-06-05

Maquet Getinge ECC Tubing Sets Recalled for Sterility Assurance Concerns

Maquet Cardiovascular is recalling specific ECC 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 risk-of-harm product (medical device) where sterility cannot be assured, but the source text explicitly states no illnesses or injuries have been reported, capping the score at 3 per the rubric.

Plain-English summary

Maquet Cardiovascular, LLC is recalling Maquet Getinge BEQ-T 39700 ECC Packs (Material: 701062473R01) used for extracorporeal circulation. The recall is due to a potential defect in the closed stopcock and non-vented cap configuration. This design may prevent the flow of humidity and ethylene oxide gas into the fluid path during the sterilization process, meaning the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured.

The affected products were distributed nationwide. The recall involves specific batch numbers: 3000056807, 3000058047, 3000061214, 3000064945, 3000068116, 3000071379, 3000071832, 3000080848, and 3000081908. The source text does not report any illnesses or injuries associated with this recall.

Healthcare facilities and users should check their inventory for the listed batch numbers and stop using the affected products. Users should contact Maquet Cardiovascular, LLC for instructions on how to return or replace the recalled items.

The recalled product

Product: Maquet Getinge- BEQ-T 39700 ECC Pack Material:701062473R01
Manufacturer: Maquet Cardiovascular, LLC
Category: Medical Device — Surgical Tubing
Hazard: 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 →

Same manufacturer · Maquet Cardiovascular, LLC

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Same hazard · sterility failure