Agency classClass IIOur severity:High FDA (Devices)·Z-1570-2019·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 involves a risk-of-harm product (medical device) where sterility cannot be assured, but the source text does not report any illnesses or injuries, fitting the 'High' severity criteria for theoretical risk without reported harm.

Plain-English summary

Maquet Cardiovascular, LLC is recalling Maquet Getinge-BEQ-TOP 31203 CUSTOM PACK NEO tubing sets used for extracorporeal circulation. The recall is due to a potential defect in the sterilization process. The closed stopcock and non-vented cap configuration may prevent humidity and ethylene oxide gas from reaching the fluid path between the closed port and the cap. As a result, the Sterility Assurance Level (SAL) for the stopcock ports cannot be assured.

The affected products are identified by the following batch numbers: 3000050481, 3000052617, 3000054413, 3000054961, and 3000055976. The distribution pattern is listed as nationwide. The source text does not specify the number of units affected or report any illnesses or injuries associated with this recall.

Healthcare facilities and users should check their inventory for these specific batch numbers. If the affected products are found, they should be removed from service and returned to the manufacturer or disposed of according to local regulations. Users should contact Maquet Cardiovascular for further instructions or replacement units.

The recalled product

Product: Maquet Getinge-BEQ-TOP 31203 CUSTOM PACK NEO Material: 701065510
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: 3000050481 3000052617 3000054413 3000054961 3000055976

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