Agency classClass IIOur severity:High FDA (Devices)·Z-1555-2019·Announced 2019-06-05

Maquet Getinge ECC Tubing Sets Recalled for Sterility Assurance Concerns

Maquet Cardiovascular is recalling specific batches of Custom Tubing Sets for Extracorporeal Circulation because a design feature may prevent proper sterilization gas flow.

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 and involves a risk of harm (potential lack of sterility) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Maquet Cardiovascular, LLC is recalling specific batches of Maquet Getinge-BEQ-TOP 21506 ECC PACK Custom Tubing Sets for Extracorporeal Circulation. The recall is due to a potential issue with the closed stopcock and non-vented cap configuration. During the sterilization process, this 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 the following batch numbers: 3000046810, 3000054159, 3000066889, and 3000074123. The material code for the product is 701064505. The recall is classified as Class II by the U.S. Food and Drug Administration. The distribution pattern is listed as nationwide.

Healthcare facilities and users should check their inventory for these specific batch numbers. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations. Users should contact Maquet Cardiovascular, LLC for further instructions regarding the return or replacement of the affected units.

The recalled product

Product: Maquet Getinge-BEQ-TOP 21506 ECC PACK Material:701064505
Manufacturer: Maquet Cardiovascular, LLC
Category: Medical Device — Surgical Tubing
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: 3000046810 3000054159 3000066889 3000074123

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