Agency classClass IIOur severity:High FDA (Devices)·Z-1597-2019·Announced 2019-06-05

Maquet Getinge ECC Pump Pack Recall Due to Sterility Assurance Concerns

Maquet Cardiovascular is recalling specific ECC Pump Packs because a design feature 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 involves a medical device where sterility cannot be assured, posing a risk of infection (high-risk hazard), but the source text does not report any illnesses or injuries, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Maquet Cardiovascular, LLC is recalling Maquet Getinge-BEQ-T 30914 ECC Pump Packs (Material: 709000011) with Batch Number 3000064952. The recall is due to a potential issue with the closed stopcock/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 non-vented cap. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured.

The affected products were distributed nationwide. The source text does not specify the number of units recalled or report any illnesses or injuries associated with the use of these devices. This is a Class II recall, indicating that use of, or exposure to, the violation may cause temporary or medically reversible adverse health consequences or the probability of serious adverse health consequences is remote.

Healthcare facilities and users should stop using the affected pump packs and contact Maquet Cardiovascular for further instructions on return or replacement. The recall is intended to ensure that only devices with assured sterility are used in extracorporeal circulation procedures.

The recalled product

Product: Maquet Getinge-BEQ-T 30914 ECC Pump Pack 1/4" Material: 709000011
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: 3000064952

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