Datascope Corporation recalls specific lots of Maquet Reinforced Introducer Sets due to potential for compromised sterility if pouches are breached. Affected units have part number 068400040305 and specific lot codes.
Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets Maquet 7 Fr., 7.5 Fr. and 8 Fr. IABs.
Datascope Corporation is recalling specific lots of Maquet Reinforced Introducer Sets because pouches in some units could become breached, risking compromised sterility. This could lead to infections if the medical device is used without proper sterilization.
The pouches in specific lots of the Reinforced Introducer Sets could breach, allowing contamination. This compromises sterility, which is critical for medical procedures involving invasive devices.
Healthcare professionals who use these sets for percutaneous insertion of intraaortic balloon catheters are most at risk. Patients using the recalled sets could face infection if sterility is compromised.
Check for part number 068400040305 on the product. Affected lots include 3000040290, 3000086802, 3000031711, 3000079613, 3000019781, 3000053099, 3000014728, 3000043100, and TTQ.
Look for part number 068400040305 and affected lot codes on the product.
The pouches in specific lots could breach, risking compromised sterility and potential infection if the device is used without proper sterilization.
Affected lots include 3000040290, 3000086802, 3000031711, 3000079613, 3000019781, 3000053099, 3000014728, 3000043100, and TTQ.
The recall does not require immediate discontinuation; check product details to confirm if your unit is affected.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-0933-2020 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-0933-2020 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.
