Agency classClass IIOur severity:High FDA (Devices)·Z-1595-2019·Announced 2019-06-05

Maquet Getinge Small Adult Cardiac Surgery Tubing Sets Recalled for Sterility Concerns

Maquet Cardiovascular is recalling specific Small Adult Cardiac Surgery Tubing Sets because a design flaw 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 (sterile medical device) where the hazard is a potential failure of sterilization, but no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Maquet Cardiovascular, LLC is recalling Maquet Getinge-BO-T 2303 Small Adult Cardiac Surgery Material (Material: 709000004). The recall affects batch numbers 3000045083 and 3000046399, which were distributed nationwide.

The recall was issued because the closed stopcock and non-vented cap configuration 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 replace the affected products.

The recalled product

Product: Maquet Getinge-BO-T 2303 Small Adult Cardiac Surgery Material:709000004
Manufacturer: Maquet Cardiovascular, LLC
Category: Medical Device — Cardiac Surgery Tubing
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: 3000045083 3000046399

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