Agency classClass IIOur severity:High FDA (Devices)·Z-1498-2019·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 the design may prevent proper sterilization gas flow, 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, but the source text does not report any specific illnesses or injuries, fitting the 'High' criteria for risk-of-harm products without reported injury.

Plain-English summary

Maquet Cardiovascular, LLC is recalling Maquet Getinge-BEQ-TOP 15800 Tubing Packs (Material 3000065087) used for extracorporeal circulation. The recall involves batch numbers 3000062267 and 3000065087, which 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 sterilization. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, potentially leaving the device non-sterile.

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

The recalled product

Product: Maquet Getinge-BEQ-TOP 15800 TUBING PACK Material: 3000065087
Manufacturer: Maquet Cardiovascular, LLC
Category: Medical Device — Surgical Tubing
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 (2)

Batch Numbers: 3000062267
3000065087

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