Agency classClass IIOur severity:Severe FDA (Devices)·Z-1521-2019·Announced 2019-06-05

Maquet Getinge-BEQ-TOP 25500 ECC Tubing Sets Recalled for Sterility Assurance Issues

Maquet Cardiovascular is recalling specific Custom Tubing Sets for Extracorporeal Circulation because the design may prevent proper sterilization gas flow, 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, and the failure to assure sterility in a device used for extracorporeal circulation poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.

Plain-English summary

Maquet Cardiovascular, LLC is recalling Custom Tubing Sets for Extracorporeal Circulation (ECC), specifically the Maquet Getinge-BEQ-TOP 25500 ECC 3/8 w/QiD model (Material: 701052461). The affected batch numbers are 3000065224 and 3000074124. The products were distributed nationwide.

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 during the sterilization process. This potential blockage means the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, creating a risk that the devices may not be sterile when used.

Healthcare facilities and users of these specific tubing sets should stop using the affected batches immediately and contact Maquet Cardiovascular for further instructions on replacement or return.

The recalled product

Product: Maquet Getinge-BEQ-TOP 25500 ECC 3/8 w/QiD Material: 701052461
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: 3000065224 3000074124

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 →

Same manufacturer · Maquet Cardiovascular, LLC

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Same hazard · sterility failure