Agency classClass IIOur severity:High FDA (Devices)·Z-1665-2019·Announced 2019-06-05

Maquet Getinge Children's ECC Tubing Sets Recalled for Sterility Assurance Concerns

Maquet Cardiovascular is recalling specific Children's Large ECC Packs 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 or harm, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Maquet Cardiovascular, LLC is recalling the Maquet Getinge-BEQ-TOP 49101 Childrens Large ECC Pack (Material: 701067069R01). The recall affects units with Batch Number 3000059724 that 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 during sterilization. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, meaning the devices may not be sterile.

Healthcare facilities and consumers should stop using these specific tubing sets immediately. Users should contact Maquet Cardiovascular for instructions on how to return or dispose of the affected products.

The recalled product

Product: Maquet Getinge-BEQ-TOP 49101 Childrens Large ECC Pack Material: 701067069R01
Manufacturer: Maquet Cardiovascular, LLC
Category: Medical Device — Cardiovascular
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: 3000059724

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