Agency classClass IIOur severity:High FDA (Devices)·Z-1501-2019·Announced 2019-06-05

Maquet Getinge Tubing Packs Recalled Due to Sterility Assurance Concerns

Maquet Cardiovascular is recalling specific tubing packs for extracorporeal circulation because a design flaw 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 sterility cannot be assured, creating a risk of harm (infection) that has not yet been reported as an injury or illness, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Maquet Cardiovascular, LLC is recalling Maquet Getinge-BEQ-TOP 5103#CPS Tubing Packs (Material: 701048690) used for extracorporeal circulation. The recall involves specific batch numbers: 3000044416, 3000049077, 3000053102, 3000054957, 3000056257, 3000061306, 3000070701, and 3000072685. These 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 during the sterilization process. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, potentially compromising the sterility of the device.

Healthcare facilities and users of these specific tubing packs should stop using the affected units and contact Maquet Cardiovascular for further instructions on return or replacement.

The recalled product

Product: Maquet Getinge-BEQ-TOP 5103#CPS Tubing Pack Material: 701048690
Manufacturer: Maquet Cardiovascular, LLC
Category: Medical Device — Surgical / Sterile Equipment
Hazard: sterility-failure
infection-risk

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