Agency classClass IIOur severity:Severe FDA (Devices)·Z-1575-2019·Announced 2019-06-05

Maquet Cardiovascular Recalls Custom Tubing Sets for Extracorporeal Circulation

Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation 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 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. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when the defect involves a fundamental safety failure like sterilization assurance in a medical device.

Plain-English summary

Maquet Cardiovascular, LLC is recalling specific batches of Maquet Getinge-BEQ-T 46500 PRIME PACK custom tubing sets used for extracorporeal circulation. The recall is due to a potential sterilization failure where the closed stopcock and non-vented cap configuration may prevent humidity and ethylene oxide gas from reaching the fluid path. This issue means the Sterility Assurance Level (SAL) of the stopcock ports cannot be guaranteed.

The affected product is identified by Material 701065823 and includes Batch Numbers 3000043849 and 3000046392. The recall is classified as Class II by the FDA, indicating a situation where use of the product could, in most cases, cause temporary or medically reversible health consequences. The product was distributed nationwide.

Healthcare facilities and users should stop using the affected tubing sets and contact Maquet Cardiovascular for instructions on return or replacement. The recall is driven by the risk that the device may not be sterile, which is a critical safety requirement for devices used in extracorporeal circulation.

The recalled product

Product: Maquet Getinge-BEQ-T 46500 PRIME PACK Material:701065823
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: 3000043849 3000046392

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