Agency classClass IIOur severity:High FDA (Devices)·Z-1668-2019·Announced 2019-06-05

Maquet Getinge Open Heart Pack Recall Due to Sterility Assurance Concerns

Maquet Cardiovascular is recalling specific Open Heart Packs because a design feature may prevent sterilization gas from reaching all parts, 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' severity criteria for risk-of-harm products without reported harm.

Plain-English summary

Maquet Cardiovascular, LLC is recalling the Maquet Getinge BEQ-TOP 40010 OPEN HEART PACK (Material: -701067364R02). The recall involves Custom Tubing Sets for Extracorporeal Circulation (ECC) with batch numbers 3000058180 and 3000062474. The products were distributed nationwide.

The recall is being issued because the closed stopcock/non-vented cap configuration may prevent the flow of humidity and ethylene oxide gas into the fluid path between the closed port and the non-vented cap during sterilization. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured.

Healthcare facilities and users should stop using the affected products and contact Maquet Cardiovascular for further instructions or replacement.

The recalled product

Product: Maquet Getinge BEQ-TOP 40010 OPEN HEART PACK Material: -701067364R02
Manufacturer: Maquet Cardiovascular, LLC
Category: Medical Device — Surgical Supplies
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: 3000058180 3000062474

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