Maquet Getinge ECC Pump Packs Recalled for Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific ECC Pump Packs because a design feature may prevent proper sterilization, potentially compromising sterility.
What this means for you
Illness, injury, or structural failure has been reported. 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. The hazard involves a failure to assure sterility in a medical device used for extracorporeal circulation, which poses a significant risk of infection or serious injury, aligning with the 'Severe' criteria for significant injury reports or high-risk device defects.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Maquet Getinge-BEQ-TOP 30907 ECC Pump Packs (Material: 701065770) due to a potential sterility issue. The recall covers units with batch numbers 3000041328 and 3000041619, which were distributed nationwide.
The recall was initiated because the closed stopcock and non-vented cap configuration on the custom tubing sets may prevent the flow of humidity and ethylene oxide gas into the fluid path during sterilization. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, meaning the devices may not be sterile.
Healthcare facilities and users should stop using the affected pump packs immediately. Maquet Cardiovascular is the recalling firm and is responsible for managing the recall process.
The recalled product
- Product
- Maquet Getinge-BEQ-TOP 30907 ECC PUMP PACK Material: 701065770
- 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: 3000041328 3000041619
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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