Agency classClass IIOur severity:High FDA (Devices)·Z-1599-2019·Announced 2019-06-05

Maquet Getinge Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation 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 is classified as FDA Class II. The hazard involves a potential failure to assure sterility in a medical device used for extracorporeal circulation, which presents a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.

Plain-English summary

Maquet Cardiovascular, LLC is recalling specific custom tubing sets for extracorporeal circulation (ECC). The affected products are identified as Maquet Getinge-BEQ-T 28906 1/4" with Bridge Ancillary P Material, with batch numbers 3000062737 and 3000068119. The recall is classified as Class II by the U.S. Food and Drug Administration.

The recall is being issued because the closed stopcock and non-vented cap configuration on these devices may prevent the flow of humidity and ethylene oxide gas into the fluid path during the sterilization process. This issue means that the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, creating a potential risk of non-sterile components.

The affected products were distributed nationwide. Healthcare facilities and users of these specific tubing sets should stop using the affected units and contact Maquet Cardiovascular for further instructions or replacement.

The recalled product

Product: Maquet Getinge-BEQ-T 28906 1/4" with Bridge Ancillary P Material: 709000072
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: 3000062737 3000068119

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