Agency classClass IIOur severity:High FDA (Devices)·Z-1569-2019·Announced 2019-06-05

Maquet Getinge ECC Tubing Sets Recalled for Sterility Assurance Concerns

Maquet Cardiovascular is recalling specific ECC tubing sets because a design flaw may prevent proper sterilization, 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 Maquet Getinge-BEQ-TOP 27609 ECC PACK 1/4" tubing sets used for extracorporeal circulation. The recall involves specific batch numbers: 3000044419, 3000045727, and 3000065141. The products were distributed nationwide.

The recall is due to a potential failure in the sterilization process. The closed stopcock and non-vented cap configuration may prevent humidity and ethylene oxide gas from reaching the fluid path between the closed port and the cap. As a result, the Sterility Assurance Level (SAL) for the stopcock ports cannot be assured, meaning the devices may not be sterile.

Healthcare facilities and users of these specific tubing sets should stop using the affected units and contact Maquet Cardiovascular for further instructions. The 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 27609 ECC PACK 1/4" Material: 701065504
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: 3000044419 3000045727 3000065141

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