Datascope Corporation recalls specific lots of Maquet Reinforced Introducer Sets due to potential for compromised sterility in breached pouches. Affected units may pose infection risks if used improperly.
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 (part number 068400040310) because pouches could breach, risking infection. This is serious for medical procedures where sterility is critical.
The pouches in specific lots may breach, allowing contamination. This could lead to infections during medical procedures where sterile conditions are essential. The risk is tied to improper handling or manufacturing defects.
Healthcare professionals using these sets for percutaneous procedures are most at risk. Patients using the sets could face infection if the pouch breaches.
Check for part number 068400040310 and lot codes 3000079612, 3000043101, 3000036631, 3000015016, or TTP. These sets are used for percutaneous insertion of MAQUET IntraAortic Balloon Catheters.
Look for part number 068400040310 and lot codes 3000079612, 3000043101, 3000036631, 3000015016, or TTP on the packaging.
The pouches in specific lots may breach, potentially compromising sterility and leading to infection during medical procedures.
The recall does not require immediate stop use; however, affected units should be checked for breach risks.
Check for part number 068400040310 and lot codes 3000079612, 3000043101, 3000036631, 3000015016, or TTP on the packaging.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-0934-2020 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-0934-2020 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.
