Agency classClass IIOur severity:High FDA (Devices)·Z-1605-2019·Announced 2019-06-05

Maquet Pediatric Cardiac Surgery Tubing Sets Recalled for Sterility Assurance Concerns

Maquet Cardiovascular is recalling specific pediatric cardiac surgery tubing sets 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 or harm to patients, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Maquet Cardiovascular, LLC is recalling Maquet Getinge-BO-T 46201 Small Pediatric Cardiac Surgery Material (Material: 709000133). The recall involves Custom Tubing Sets for Extracorporeal Circulation (ECC) distributed nationwide. The specific batch numbers affected are 3000044424, 3000046488, 3000049459, 3000055093, and 3000060357.

The recall was initiated 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, meaning the devices may not be sterile when used.

This recall affects healthcare facilities and providers who have purchased or received these specific tubing sets. Users should stop using the affected devices and contact Maquet Cardiovascular, LLC for instructions on return or replacement. No specific dates or quantities are provided in the source text.

The recalled product

Product: Maquet Getinge-BO-T 46201 Small Pediatric Cardiac Surge Material: 709000133
Manufacturer: Maquet Cardiovascular, LLC
Category: Medical Device — Cardiac Surgery Equipment
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: 3000044424 3000046488 3000049459 3000055093 3000060357

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