Agency classClass IIOur severity:High FDA (Devices)·Z-1604-2019·Announced 2019-06-05

Maquet Getinge Cardioplegia Packs Recalled for Sterility Assurance Concerns

Maquet Cardiovascular is recalling specific batches of Getinge-BO-T 52360 Cardioplegia Packs because a design feature 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 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 the Sterility Assurance Level cannot be assured, creating a risk of harm from potential contamination, but the source text does not report any specific illnesses or injuries.

Plain-English summary

Maquet Cardiovascular, LLC is recalling specific batches of Maquet Getinge-BO-T 52360 Cardioplegia Packs (Material: 709000127). The affected batch numbers are 3000053531, 3000060033, and 3000067120. The products were distributed nationwide.

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 during sterilization. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured.

Healthcare facilities and consumers should stop using these specific batches of cardioplegia packs. Users should contact Maquet Cardiovascular for further instructions on how to return or dispose of the affected products.

The recalled product

Product: Maquet Getinge-BO-T 52360 Cardioplegia Pack Material: 709000127
Manufacturer: Maquet Cardiovascular, LLC
Category: Medical Device — Cardiac Surgery 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: 3000053531 3000060033 3000067120

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