Agency classClass IIOur severity:High FDA (Devices)·Z-1636-2019·Announced 2019-06-05

Maquet Getinge Adult ECC Pack Recall Due to Sterility Assurance Concerns

Maquet Cardiovascular is recalling Adult ECC Packs because a design feature may prevent sterilization gas from reaching all fluid paths, 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 or illnesses in the source text, which aligns with the 'High' severity criteria.

Plain-English summary

Maquet Cardiovascular, LLC is recalling Maquet Getinge-BEQ-TOP 24101 Adult ECC Packs (Material: 701050177R01) due to a potential sterility assurance issue. The recall affects specific batch numbers, including 3000042145 and 3000056049, which were distributed nationwide.

The recall was initiated because the closed stopcock and non-vented cap configuration on the custom tubing sets may prevent the flow of humidity and ethylene oxide gas into the fluid path between the closed port and the cap. This design limitation means the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, potentially leaving the device non-sterile.

Healthcare facilities and consumers should stop using the affected products immediately and contact Maquet Cardiovascular for instructions on return or replacement. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product: Maquet Getinge-BEQ-TOP 24101 Adult ECC Pack Material:701050177R01
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: 3000042145 3000056049

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