Agency classClass IIOur severity:High FDA (Devices)·Z-1661-2019·Announced 2019-06-05

Maquet Getinge Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation 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 is classified as FDA Class II and involves a risk of harm (potential lack of sterility) where injury has not yet been reported, which aligns with the 'High' severity criteria for risk-of-harm products without reported illness.

Plain-English summary

Maquet Cardiovascular, LLC is recalling specific custom tubing sets for extracorporeal circulation (ECC) under FDA recall number Z-1661-2019. The affected products are identified by the description "Maquet Getinge-BEQ-TOP 41201 ECC 3/8 Pump Pack Wake For Material: 701064867R01" and include batch numbers 3000080724 and 3000084928. The recall is classified as Class II by the FDA.

The recall is issued because the closed stopcock and non-vented cap configuration on these devices may prevent the flow of humidity and ethylene oxide gas into the fluid path during the sterilization process. As a result, the Sterility Assurance Level (SAL) for the stopcock ports cannot be assured, meaning the devices may not be fully sterile.

The affected products were distributed nationwide. Healthcare facilities and users should stop using the affected tubing sets and contact Maquet Cardiovascular for instructions on return or replacement. No specific illnesses or injuries have been reported in the source text.

The recalled product

Product: Maquet Getinge- BEQ-TOP 41201 ECC 3/8 Pump Pack Wake For Material: 701064867R01
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: 3000080724 3000084928

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 →

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Same hazard · sterility failure