Agency classClass IIOur severity:High FDA (Devices)·Z-1556-2019·Announced 2019-06-05

Maquet Getinge ECC Tubing Sets Recalled for Sterility Assurance Concerns

Maquet Cardiovascular is recalling specific batches of Getinge-BEQ-T 5211 Large ECC Sets because a design feature may prevent proper sterilization.

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 harm (infection) even though no injuries have been reported yet, fitting the 'High' criteria for risk-of-harm products.

Plain-English summary

Maquet Cardiovascular, LLC is recalling the Maquet Getinge-BEQ-T 5211 Large ECC Set (Material: 701064560). The recall affects specific batch numbers: 3000041128, 3000045731, 3000050577, 3000052947, 3000054617, 3000054955, 3000057631, and 3000071818. These products were 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 during sterilization. This issue means the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, potentially compromising the sterility of the device.

This recall is classified as Class II by the FDA. No specific illnesses or injuries are reported in the source text. Healthcare facilities and consumers should stop using the affected products and contact the manufacturer for further instructions.

The recalled product

Product: Maquet Getinge-BEQ-T 5211 LARGE ECC SET Material:701064560
Manufacturer: Maquet Cardiovascular, LLC
Category: Medical Device — Cardiovascular / Extracorporeal Circulation
Hazard: sterility-failure
infection-risk

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