Agency classClass IIOur severity:Severe FDA (Devices)·Z-1615-2019·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 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 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 with potential for adverse health consequences (such as infection from non-sterile medical devices) are categorized as Severe (Score 4), especially given the critical nature of extracorporeal circulation where sterility is vital.

Plain-English summary

Maquet Cardiovascular, LLC is recalling Custom Tubing Sets for Extracorporeal Circulation (ECC) due to a potential sterilization failure. The recall involves specific batch numbers: 3000048719, 3000062269, 3000074321, and 3000077543. The product is identified as Maquet Getinge-BEQ-T 36507 Accessory Pk Mercy Material: 709000390.

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 between the closed port and the cap. This design issue means the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, potentially leaving the device non-sterile.

The recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The distribution pattern is listed as nationwide. Healthcare facilities and users should stop using the affected tubing sets and contact the manufacturer for further instructions.

The recalled product

Product: Maquet Getinge-BEQ-T 36507 Accessory Pk Mercy Material: 709000390
Manufacturer: Maquet Cardiovascular, LLC
Category: Medical Device — Cardiovascular / Extracorporeal Circulation
Hazard: infection
sterilization-failure

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: 3000048719 3000062269 3000074321 3000077543

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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