Maquet Getinge-BEQ-TOP 35503 SGD Pack Recall 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.
What this means for you
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, and the hazard involves a potential failure of sterility assurance for a medical device used in extracorporeal circulation, which poses a risk of harm (infection) even though no specific injuries are reported in the text.
Plain-English summary
Maquet Cardiovascular, LLC is recalling specific batches of Maquet Getinge-BEQ-TOP 35503 SGD Packs, which are Custom Tubing Sets used for Extracorporeal Circulation (ECC). The recall is due to a potential issue with the sterilization process. The closed stopcock and non-vented cap configuration on these devices 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, meaning the devices may not be fully sterile.
The affected products are identified by the following batch numbers: 3000048720, 3000058736, 3000063950, 3000070973, 3000072680, and 3000075283. The material number for these packs is 701068797. The recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Healthcare facilities and users should stop using the affected tubing sets and contact Maquet Cardiovascular for instructions on how to return or dispose of the products. The source text does not specify a distribution scope beyond the batch numbers, nor does it report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Maquet Getinge-BEQ-TOP 35503 SGD Pack Material: 701068797
- 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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