Maquet Getinge-BEQ-TOP 5900 Custom Tubing Sets Recalled for Sterility Concerns
Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design flaw 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. According to the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving significant risks such as compromised sterility in medical devices, even if specific hospitalization reports are not explicitly detailed in the provided text snippet.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Maquet Getinge-BEQ-TOP 5900 3/8 Quadrox iD Pack w/BB custom tubing sets used for extracorporeal circulation. 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 reaching the fluid path between the closed port and the cap. As a result, the Sterility Assurance Level (SAL) for the stopcock ports cannot be assured.
The affected products are identified by the following batch numbers: 3000048233, 3000048397, 3000054333, 3000058183, 3000069469, and 3000074100. The material number is 701050228. 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 users should stop using the affected tubing sets and contact Maquet Cardiovascular for further instructions on returns or replacements. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Maquet Getinge-BEQ-TOP 5900 3/8 Quadrox iD Pack w/BB Material: 701050228
- Manufacturer
- Maquet Cardiovascular, LLC
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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