Agency classClass IIOur severity:High FDA (Devices)·Z-1606-2019·Announced 2019-06-05

Maquet Getinge-BEQ-T 8506 Transport Pack Recalled for Sterility Assurance Issues

Maquet Cardiovascular is recalling Custom Tubing Sets for Extracorporeal Circulation because the stopcock design may prevent sterilization gas from reaching the fluid path, 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, creating a risk of infection or harm. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Maquet Cardiovascular, LLC is recalling Custom Tubing Sets for Extracorporeal Circulation (ECC), specifically the Maquet Getinge-BEQ-T 8506 Transport Pack (Material: 709000146). The recall involves Batch Number 3000075713, which 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 between the closed port and the cap during sterilization. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, meaning the product may not be sterile.

Healthcare facilities and users of these transport packs should stop using the affected units immediately. Users should contact Maquet Cardiovascular for instructions on how to return or dispose of the recalled products.

The recalled product

Product: Maquet Getinge-BEQ-T 8506 Transport Pack Material: 709000146
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: 3000075713

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