Maquet recalls specific batch numbers of ECC 1/4" AV LOOP tubing for potential sterility issues during sterilization. Affected units may not meet sterility standards if improperly configured.
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 certain batches of ECC 1/4" AV LOOP tubing due to a risk that the tubing may not meet sterility standards after sterilization. This could lead to infections if the tubing is used in medical procedures.
During sterilization, the tubing's closed stopcock configuration may block humidity and ethylene oxide gas from flowing into the fluid path. This can compromise the sterility assurance level, potentially leading to infections if the tubing is used in medical procedures.
Healthcare professionals using the Maquet Getinge-BEQ-TOP 21503 ECC 1/4" AV LOOP tubing for extracorporeal circulation. Patients undergoing procedures with this tubing are at risk if the tubing fails to maintain sterility.
Check for the batch numbers: 3000043295, 3000047248, 3000047254, 3000055638, 3000062271, 3000065551, 3000069074, 3000075386. The product is labeled as Maquet Getinge-BEQ-TOP 21503 ECC 1/4" AV LOOP with material code 701054776.
Identify the batch numbers listed: 3000043295, 3000047248, 3000047254, 3000055638, 3000062271, 3000065551, 3000069074, 3000075386.
The tubing's closed stopcock configuration may prevent humidity and ethylene oxide gas from flowing into the fluid path during sterilization, potentially compromising sterility assurance.
The recall does not specify a remedy, so contact Maquet directly for guidance on handling affected units.
The recall indicates a potential risk to sterility, but the product may still be safe if used correctly with proper sterilization procedures.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1534-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1534-2019 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.
