Maquet recalls Mercy Med 4903 tubing sets with batch numbers 3000041468-3000084050 due to potential sterility issues during sterilization. Affected units may not maintain sterility assurance levels.
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 Mercy Med 4903 tubing sets that could fail to maintain sterility during sterilization. This poses a risk of infection if the equipment is used without proper sterilization.
During sterilization, the tubing's closed stopcock configuration may trap humidity and ethylene oxide gas, preventing proper sterilization. This could lead to the tubing not being sterile after processing, increasing infection risk.
Healthcare professionals using the Mercy Med 4903 tubing sets for extracorporeal circulation. Patients receiving treatments through these sets are at risk of infection if the equipment is not properly sterilized.
Check for batch numbers 3000041468 through 3000084050 on the product label. The product is labeled as 'Maquet Getinge-BEQ-T 4903 Mercy Med w/o Oxy' with material code 701066664.
Look for batch numbers 3000041468 through 3000084050 on the product label.
The tubing set's closed stopcock configuration may prevent proper humidity and ethylene oxide gas flow during sterilization, risking inadequate sterility assurance.
Batch numbers 3000041468, 3000053105, 3000054552, 3000057683, 3000059795, 3000065086, 3000067186, 3000069077, 3000071375, 3000072684, 3000074341, 3000075431, 3000078942, 3000080722, 3000081524, and 3000084050.
Check the product label for batch numbers listed above or the material code 701066664.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1581-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1581-2019 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.
