Agency classClass IIOur severity:High FDA (Devices)·Z-1625-2019·Announced 2019-06-05

Maquet Getinge Rotaflow Support Pack Recalled Due to Sterility Assurance Concerns

Maquet Cardiovascular is recalling specific Rotaflow Support 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 risk-of-harm product (medical device) where sterility cannot be assured, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for theoretical risk without reported harm.

Plain-English summary

Maquet Cardiovascular, LLC is recalling the Maquet Getinge-BEQ-T 48003 Rotaflow ONLY Support Pack (Material: 709000490). The recall affects batch numbers 3000074503, 3000078944, and 3000081155, which were distributed nationwide.

The recall was initiated because the closed stopcock and non-vented cap configuration may prevent humidity and ethylene oxide gas from reaching the fluid path during sterilization. As a result, the Sterility Assurance Level (SAL) for the stopcock ports cannot be assured, posing a risk of non-sterile medical devices.

Healthcare facilities and users should stop using the affected units and contact Maquet Cardiovascular for further instructions on replacement or return.

The recalled product

Product: Maquet Getinge-BEQ-T 48003 Rotaflow ONLY Support Pack Material:709000490
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: 3000074503 3000078944 3000081155

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