Agency classClass IIOur severity:High FDA (Devices)·Z-1523-2019·Announced 2019-06-05

Maquet Pediatric ECC Tubing Sets Recalled for Sterility Assurance Concerns

Maquet Cardiovascular is recalling specific pediatric extracorporeal circulation tubing sets 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 of sterilization (SAL) for a medical device used in extracorporeal circulation, which poses a risk of infection or harm, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Maquet Cardiovascular, LLC is recalling specific lots of Maquet Getinge-BEQ-TOP 31000 Pediatric Extracorporeal Circulation (ECC) Custom Tubing Sets. The recall is due to a potential defect in the sterilization process. The closed stopcock and non-vented cap configuration may prevent humidity and ethylene oxide gas from flowing into the fluid path between the closed port and the cap. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured.

The affected product is identified by Material Number 701052843. The specific batch numbers involved in this recall are 3000058044, 3000062463, and 3000075430. The product was distributed nationwide.

Healthcare facilities and users should stop using the affected tubing sets and contact Maquet Cardiovascular for instructions on return or replacement. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product: Maquet Getinge-BEQ-TOP 31000 PEDIATRIC ECC Material:701052843
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: 3000058044 3000062463 3000075430

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