Agency classClass IIOur severity:High FDA (Devices)·Z-1505-2019·Announced 2019-06-05

Maquet Small Patient Tubing Recalled Due to Sterility Assurance Concerns

Maquet Cardiovascular is recalling specific Small Patient Tubing Packs because a design flaw 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 pathogen exposure) without reported illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Maquet Cardiovascular, LLC is recalling the Maquet Getinge-BEQ-T 9403 Small Patient Tubing Pack (Material: 701049994). The recall involves specific batch numbers: 3000041414, 3000047036, 3000050575, and 3000051657. The product was distributed nationwide.

The recall is due to a potential issue with the sterilization process. The closed stopcock and non-vented cap configuration may prevent humidity and ethylene oxide gas from reaching the fluid path between the closed port and the cap. As a result, the Sterility Assurance Level (SAL) for the stopcock ports cannot be assured, meaning the sterility of these components is not guaranteed.

Healthcare facilities and consumers should check their inventory for the affected batch numbers. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations. No specific instructions for end-users are provided in the source text beyond the identification of the defect.

The recalled product

Product: Maquet Getinge-BEQ-T 9403 Small Patient Tubing Pack Material: 701049994
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: 3000041414 3000047036 3000050575 3000051657

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