Maquet Getinge E-Circuit Bioline Heparin Tubing Sets Recalled for Sterility Concerns
Maquet Cardiovascular is recalling specific batches of BEQ-TOP 37200 E-Circuit Bioline Heparin 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 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. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as compromised sterility leading to infection risk) are categorized as Severe (Score 4), particularly when no specific hospitalization reports are cited but the defect is structural/process-related affecting safety.
Plain-English summary
Maquet Cardiovascular, LLC is recalling specific batches of Maquet Getinge BEQ-TOP 37200 E-Circuit Bioline Heparin custom tubing sets used for extracorporeal circulation. The recall is due to a potential issue with the closed stopcock and non-vented cap configuration. During the sterilization process, this configuration may prevent the flow of humidity and ethylene oxide gas 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 the following batch numbers: 3000076762, 3000077899, 3000078013, and 3000084649. The material code is 701055388R01. The 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 adverse health consequences.
Healthcare facilities and distributors should stop using the affected tubing sets and contact Maquet Cardiovascular for instructions on return or replacement. Patients who have used these specific batches should consult their healthcare provider if they have concerns regarding potential sterility issues.
The recalled product
- Product
- Maquet Getinge- BEQ-TOP 37200 E-Circuit Bioline Heparin Material: 701055388R01
- Manufacturer
- Maquet Cardiovascular, LLC
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: 3000076762 3000077899 3000078013 3000084649
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.
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