Agency classClass IIOur severity:High FDA (Devices)·Z-1509-2019·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 a design feature may prevent proper sterilization gas flow, 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 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 of sterilization (SAL not assured) for a medical device used in extracorporeal circulation, which poses a risk of infection or harm, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Maquet Cardiovascular, LLC is recalling specific batches of Maquet Getinge-BEQ-TOP 22701 Custom Tubing Sets for Extracorporeal Circulation (ECC). The recall is due to a potential defect in 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.

The affected product is identified by Material 701050790 and includes Batch Numbers 3000060359, 3000060495, 3000062725, and 3000071781. The distribution pattern is listed as nationwide. No specific dates or unit counts are provided in the source text.

Healthcare facilities and users should stop using the affected tubing sets and contact Maquet Cardiovascular, LLC for further instructions or replacement. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product: Maquet Getinge-BEQ-TOP 22701 Material: 701050790
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: 3000060359 3000060495 3000062725 3000071781

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