Agency classClass IIOur severity:Severe FDA (Devices)·Z-1547-2019·Announced 2019-06-05

Maquet Getinge ECC Tubing Sets Recalled Due to Sterility Assurance Concerns

Maquet Cardiovascular is recalling specific batches of Getinge-BEQ-TOP 38900 ECC Packs because a design flaw may prevent proper sterilization of the stopcock ports.

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 source text identifies an FDA Class II recall involving a medical device where the Sterility Assurance Level cannot be assured. Per the rubric, FDA Class II recalls involving significant safety concerns like sterility failure are classified as Severe (Score 4), as they carry a risk of serious injury or death if the device is not sterile.

Plain-English summary

Maquet Cardiovascular, LLC is recalling specific batches of Maquet Getinge-BEQ-TOP 38900 ECC Packs (Material: 701056368). The recall affects Custom Tubing Sets for Extracorporeal Circulation (ECC) distributed nationwide. The affected batch numbers are 3000041396, 3000044053, 3000047317, 3000050887, 3000058131, 3000060487, 3000060723, 3000062458, 3000064724, 3000071815, and 3000071817.

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 between the closed port and the cap. This issue means the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured during the sterilization process.

Healthcare facilities and users of these devices should check their inventory for the listed batch numbers. If the affected products are found, they should be removed from service and returned to the manufacturer or disposed of according to local regulations. No specific instructions for end-users are provided in the source text, but medical professionals should verify the sterility status of any devices in use.

The recalled product

Product: Maquet Getinge-BEQ-TOP 38900 ECC PACK Material: 701056368
Manufacturer: Maquet Cardiovascular, LLC
Category: Medical Device — Cardiovascular / Extracorporeal Circulation
Hazard: sterility-failure
infection-risk

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