Maquet Getinge Custom Tubing Sets Recalled Due to Sterility Assurance Concerns
Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because the stopcock design may prevent sterilization gas from reaching all fluid paths.
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 risk-of-harm product (potential sterility failure) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Maquet Getinge-BEQ-TOP 5909 1/4 PACK W QPID custom tubing sets for extracorporeal circulation. The recall involves specific batch numbers, including 3000043679, 3000047252, 3000050833, 3000053134, 3000054956, 3000056048, 3000060481, 3000063710, 3000067185, 3000071400, 3000073429, 3000075387, and 3000075899. The product was 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 between the closed port and the cap. This design issue means the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured during the sterilization process.
Healthcare facilities and consumers should stop using the affected tubing sets and contact Maquet Cardiovascular for further instructions or a replacement. The U.S. Food and Drug Administration has classified this as a Class II recall.
The recalled product
- Product
- Maquet Getinge-BEQ-TOP 5909 1/4 PACK W QPID Material: 701064992
- Manufacturer
- Maquet Cardiovascular, LLC
- Category
- Medical Device — Cardiovascular
- Hazard
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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