Agency classClass IIOur severity:Severe FDA (Devices)·Z-1537-2019·Announced 2019-06-05

Maquet Getinge ECC Tubing Sets Recalled for Sterility Assurance Concerns

Maquet Cardiovascular is recalling specific ECC tubing sets 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a potential failure of sterilization in a critical medical device, which aligns with the rubric criteria for Severe severity (FDA Class II with significant risk).

Plain-English summary

Maquet Cardiovascular, LLC is recalling Maquet Getinge-BEQ-T 8025 1/4" ECC Packs with RF32 (Material: 701055142). The recall involves specific batch numbers: 3000044427, 3000054806, 3000059172, and 3000069470. 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. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, which poses a risk of non-sterile medical devices being used in extracorporeal circulation procedures.

Healthcare facilities and distributors should identify and quarantine the affected units. Users should stop using these specific tubing sets and contact Maquet Cardiovascular for instructions on return or replacement.

The recalled product

Product: Maquet Getinge-BEQ-T 8025 1/4" ECC Pack with RF32 Material:701055142
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: 3000044427 3000054806 3000059172 3000069470

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