Maquet Cardiovascular, LLC Maquet Getinge-BEQ-TOP 24500 ADULT ECC Material: 701050253 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Maquet Getinge-BEQ-TOP 24500 ADULT ECC Material: 701050253
Brand
Maquet Cardiovascular, LLC
Lot Codes / Batch Numbers
Batch Numbers: 3000041126 3000053053 3000054958 3000055326 3000064943 3000066814 3000071782
Products Sold
Batch Numbers: 3000041126 3000053053 3000054958 3000055326 3000064943 3000066814 3000071782
Maquet Cardiovascular, LLC is recalling Maquet Getinge-BEQ-TOP 24500 ADULT ECC Material: 701050253 due to Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
Maquet Getinge issued recall notification letter on April 18, 2019 via FedEx 2-day delivery identifies issue, health risk and action to take: quarantine and return to Maquet/Getinge recalled product. Complete response form and return to acknowledge this recall. Questions contact Getinge Customer Service at 1 888 627 8383 (press option 2, then option 2) between the hours of 8 AM and 6 PM Eastern Standard Time. On 3/26/20 firm expanded recall to include an additional lot for one consignee,product: "BEQ TOP 25003 3/8 3/8 up to 7 lpm", item number 701063255R02, lot 3000087051.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026