Agency classClass IIOur severity:Severe FDA (Devices)·Z-1515-2019·Announced 2019-06-05

Maquet Getinge ECC 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, and the rubric specifies that FDA Class II recalls involving significant risks or potential for serious injury (such as sterility failure in medical devices) are rated as Severe (4).

Plain-English summary

Maquet Cardiovascular, LLC is recalling Custom Tubing Sets for Extracorporeal Circulation (ECC) with the material number 701051179. The affected products are identified by batch numbers 3000045170, 3000058051, 3000062455, and 3000065508. The recall is classified as Class II by the FDA.

The recall is being issued 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. 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 should stop using the affected tubing sets and contact Maquet Cardiovascular for instructions on how to return or replace the products.

The recalled product

Product: Maquet Getinge-BEQ-TOP 22702 ECC W/HMOD 30000 Material: 701051179
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 (1)

Batch Numbers: 3000045170 3000058051 3000062455 3000065508

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