Maquet recalls specific pressure pigtails for potential sterility issues during sterilization. Affected units have batch numbers 3000058045, 3000069467, 3000072507, 3000080702. Contact for remedy.
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 pressure pigtails used in medical sterilization due to a risk that they might not maintain sterility after processing. This could lead to infections if the equipment is used improperly.
During sterilization, the tubing's closed stopcock design may trap humidity and ethylene oxide gas, preventing proper sterility assurance. This could lead to contamination if the equipment is reused without proper sterilization.
Healthcare professionals using these pressure pigtails in medical sterilization equipment. Those handling the specific batch numbers listed are most at risk.
Check for batch numbers 3000058045, 3000069467, 3000072507, or 3000080702 on the product label. The product is a 6" pressure pigtails with material code 701055995.
Look for batch numbers 3000058045, 3000069467, 3000072507, or 3000080702 on the product label.
The tubing's closed stopcock design may trap humidity and ethylene oxide gas during sterilization, potentially compromising sterility assurance.
Check for batch numbers 3000058045, 3000069467, 3000072507, or 3000080702 on the product label.
The recall record does not specify a remedy, so contact Maquet for further instructions.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1545-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1545-2019 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.
