Maquet recalls BO-T 2303 3/8" x 3/8" Adult Pack material 709000004R01 due to potential sterility issues during sterilization. Affected units have batch numbers starting with 3000058327. 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 a specific adult tubing pack used in medical sterilization because improper sterilization could lead to contamination. This affects hospitals and medical facilities using the product.
During sterilization, the tubing's closed stopcock design may trap humidity and ethylene oxide gas, preventing proper sterility assurance. This could lead to contaminated medical equipment if not properly sterilized.
Medical facilities and hospitals that use the Maquet Getinge BO-T 2303 3/8" x 3/8" Adult Pack material 709000004R01 are most at risk. The recall targets specific batch numbers produced by the manufacturer.
Check for the product name 'BO-T 2303 3/8" x 3/8" Adult Pack' with material code 709000004R01. Affected units have batch numbers starting with 3000058327.
Identify the material code 709000004R01 and batch numbers starting with 3000058327 on the packaging.
The recall is due to a potential sterility risk during sterilization caused by the tubing's closed stopcock design.
The official recall notice does not specify a remedy or action steps beyond checking product details.
Batch numbers starting with 3000058327 are affected.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1673-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1673-2019 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.
