Maquet Getinge Custom Tubing Sets Recalled 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 involves a risk-of-harm product (medical device) where the sterilization process may be compromised, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for theoretical risk without reported harm.
Plain-English summary
Maquet Cardiovascular, LLC is recalling specific lots of Maquet Getinge Custom Tubing Sets for Extracorporeal Circulation (ECC). The affected products include material numbers 701053941R01 and 701053941R02, specifically the BEQ-TOP 9005 3/8 Custom Pk w/RF32 & HMOD. The recall covers specific batch numbers: 3000051652, 3000054808, 3000058733, 3000062473, 3000071201, 3000073170, 3000075123, 3000076148, and 3000081600.
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 during the sterilization process. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, which poses a risk of non-sterile components being used in medical procedures.
The products were distributed nationwide. Healthcare facilities and users of these specific tubing sets should stop using the affected lots and contact Maquet Cardiovascular, LLC for further instructions on return or replacement.
The recalled product
- Product
- Maquet Getinge: (1) Material: 701053941R01 BEQ-TOP 9005 3/8 Custom Pk w/RF32 & HMOD (2) Material: 701053941R02- BEQ-TOP 9005 3/8 Custom Pk w RF32 & HMOD Material:
- Manufacturer
- Maquet Cardiovascular, LLC
- Category
- Medical Device — Surgical Tubing
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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