Agency classClass IIOur severity:High FDA (Devices)·Z-1558-2019·Announced 2019-06-05

Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because the stopcock design 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 (risk-of-harm product), but the source text does not report any actual illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Maquet Cardiovascular, LLC is recalling Maquet Getinge-BEQ-T 30601 CMC Accessory Kits (Material: 701064701) used for custom tubing sets in extracorporeal circulation. The recall involves batch numbers 3000054160, 3000057639, and 3000058046, which were distributed nationwide.

The recall is due to a potential defect in the sterilization process. The closed stopcock and non-vented cap configuration may prevent humidity or ethylene oxide gas from flowing 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, meaning the devices may not be sterile.

Healthcare facilities and users of these specific accessory kits should stop using the affected units and contact Maquet Cardiovascular for further instructions or replacement. The source text does not report any specific illnesses or injuries associated with this recall.

The recalled product

Product: Maquet Getinge-BEQ-T 30601 CMC ACCESSORY KIT Material: 701064701
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: 3000054160 3000057639 3000058046

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