Maquet recalls Getinge-BEQ-TOP 37200 CIRCULATORY CIRC tubing sets with specific batch numbers due to potential sterility issues during sterilization. Affected units may not meet sterility standards if humidity/ethylene oxide gas cannot flow properly.
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
Maquet is recalling specific batches of Getinge-BEQ-TOP 37200 CIRCULATORY CIRC tubing sets because improper sterilization could lead to contamination. This affects medical devices used in extracorporeal circulation systems.
During sterilization, the tubing's closed stopcock design can block humidity and ethylene oxide gas from flowing into the fluid path. This prevents proper sterility assurance, potentially leading to contamination of the device.
Healthcare professionals using the Getinge-BEQ-TOP 37200 CIRCULATORY CIRC tubing sets for extracorporeal circulation procedures are most at risk. Patients using these devices during sterilization may face contamination.
Check for batch numbers: 3000044291, 3000046812, 3000048395, 3000051270, 3000054144, 3000055979, 3000058735, 3000061304, 3000063708, 3000066691, 3000070702, 3000072307, 3000075122. The product is labeled as Maquet Getinge-BEQ-TOP 37200 CIRCULATORY CIRC with material code 701055388.
Look for batch numbers on the tubing set: 3000044291, 3000046812, 3000048395, 3000051270, 3000054144, 3000055979, 3000058735, 3000061304, 3000063708, 3000066691, 3000070702, 3000072307, 3000075122.
The tubing set's closed stopcock design may prevent proper humidity and ethylene oxide gas flow during sterilization, risking contamination.
Batch numbers: 3000044291, 3000046812, 3000048395, 3000051270, 3000054144, 3000055979, 3000058735, 3000061304, 3000063708, 3000066691, 3000070702, 3000072307, 3000075122.
Patients using the tubing set during extracorporeal circulation procedures may face contamination risks if the device is not properly sterilized.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1539-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1539-2019 from Maquet. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
