Agency classClass IIOur severity:High FDA (Devices)·Z-1626-2019·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 the stopcock design may prevent sterilization gas from reaching all fluid paths.

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 assure sterility in a medical device used for extracorporeal circulation, which poses a risk of harm, but the source text does not report any specific illnesses or injuries, placing it in the High severity category per the rubric.

Plain-English summary

Maquet Cardiovascular, LLC is recalling specific custom tubing sets for extracorporeal circulation (ECC). The affected product is the Maquet Getinge-BEQ-TOP 31603 CHKD 3/8" ECC, with material number 709000516 and batch number 3000083879. The recall is classified as Class II by the U.S. Food and Drug Administration.

The recall is being issued 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. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured during the sterilization process.

The affected products were distributed nationwide. No specific number of affected units is provided in the source text. Healthcare facilities and consumers should stop using the affected tubing sets and contact Maquet Cardiovascular for further instructions or replacement.

The recalled product

Product: Maquet Getinge-BEQ-TOP 31603 CHKD 3/8" ECC Material: 709000516
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: 3000083879

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