Maquet recalls specific bladder packs for potential sterility issues during sterilization. The closed stopcock design may prevent proper humidity and gas flow, risking contamination. Affected units have batch numbers 3000048718, 3000052045, 3000060037, 3000074174.
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 bladder packs due to a risk that the stopcock design might not allow proper humidity and gas flow during sterilization. This could lead to contamination of medical equipment, making the packs unsafe for use.
During sterilization, the closed stopcock design may prevent humidity and ethylene oxide gas from flowing into the fluid path between the port and cap. This could compromise the sterility assurance level, potentially contaminating medical equipment.
Healthcare professionals using the Maquet Getinge-BEQ-T 25501 3/8" Better Bladder Pack with batch numbers 3000048718, 3000052045, 3000060037, or 3000074174 are most at risk. These packs are used in medical settings for extracorporeal circulation.
Check the batch number on the pack: 3000048718, 3000052045, 3000060037, or 3000074174. The product is the Maquet Getinge-BEQ-T 25501 3/8" Better Bladder Pack with material code 709000370.
Verify the batch number on the pack is one of 3000048718, 3000052045, 3000060037, or 3000074174.
Reach out to Maquet Cardiovascular for further guidance on handling affected units.
The affected batch numbers are 3000048718, 3000052045, 3000060037, and 3000074174.
The closed stopcock design may prevent proper humidity and ethylene oxide gas flow during sterilization, risking contamination of medical equipment.
No immediate stop is required, but affected units should be checked and contacted for guidance.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1613-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1613-2019 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.
