Agency classClass IIOur severity:High FDA (Devices)·Z-1680-2019·Announced 2019-06-05

Maquet Custom Tubing Sets Recalled for Sterility Assurance Concerns

Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design feature may prevent sterilization gas from reaching all parts of the device.

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. The hazard involves a potential failure to achieve sterility in a medical device used for extracorporeal circulation, which poses a risk of infection, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Maquet Cardiovascular, LLC is recalling custom tubing sets for extracorporeal circulation (ECC). The specific product involved is the Maquet Getinge BEQ-TOP 54500 BSW-McLANE 3/8 Quadrox iD, with material number 709000496R01 and batch number 3000077081. The recall is classified as Class II by the FDA.

The recall is due to a potential issue with the sterilization process. The closed stopcock and non-vented cap configuration may prevent the flow of humidity and ethylene oxide gas into the fluid path between the closed port and the cap. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, meaning the device may not be fully sterile.

The affected products were distributed nationwide. Healthcare facilities and users of these specific tubing sets should stop using the affected units and contact Maquet Cardiovascular for further instructions on replacement or return.

The recalled product

Product: Maquet Getinge- BEQ-TOP 54500 BSW-McLANE 3/8 Quadrox iD Material:709000496R01
Manufacturer: Maquet Cardiovascular, LLC
Category: Medical Device — Extracorporeal Circulation Tubing
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: 3000077081

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