Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Maquet Getinge- BEQ-TOP 41201 ECC 3/8 Pump Pack Wake For Recalled by Maquet Cardiovascular, LLC Due to Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization,...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Maquet Cardiovascular, LLC directly.
Affected Products
Maquet Getinge- BEQ-TOP 41201 ECC 3/8 Pump Pack Wake For Material: 701064867R01
Quantity: N/A
Why Was This Recalled?
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Maquet Cardiovascular, LLC
Maquet Cardiovascular, LLC has 251 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report