Maquet recalls specific Mercy Medical Versa-Pack material for potential sterility issues during sterilization. Affected units have batch numbers starting with 3000043162. Consumers should contact the manufacturer for details.
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 a specific Mercy Medical Versa-Pack material used in medical devices because it may not maintain sterility during sterilization. This could lead to infections if the device is used improperly after sterilization.
During sterilization, the closed stopcock design may trap humidity and ethylene oxide gas, preventing proper sterility assurance. This could lead to contamination if the device is used without being fully sterile.
Healthcare professionals using the specific Mercy Medical Versa-Pack material (batch numbers starting with 3000043162) are most at risk. Patients receiving treatments with this material could face infection risks.
Check for the batch number starting with 3000043162 on the Mercy Medical Versa-Pack material. The product is part of the Maquet Getinge-BEQ-T 4917 line.
Reach out to Maquet Cardiovascular, LLC for specific instructions on handling the recalled item.
The recall indicates a potential sterility risk during sterilization, so it is not recommended for use until the manufacturer provides instructions.
Batch numbers starting with 3000043162 are affected.
Look for the batch number starting with 3000043162 on the Mercy Medical Versa-Pack material.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1612-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1612-2019 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.
