Datascope recalls specific Intra-Aortic Balloon Catheter kits (Japan) due to potential endotoxin contamination. Affected kits have lot numbers listed; users should contact Datascope for details.
Potential Endotoxin Contamination
Datascope is recalling certain Intra-Aortic Balloon Catheter kits (Japan) because they may contain endotoxins. This could cause infections or other health issues during medical procedures. Patients using these kits should contact Datascope for guidance.
Endotoxins are toxic substances found in the outer membrane of bacteria. If present in medical devices, they can cause infections or adverse reactions when used in procedures. This risk is specific to the recalled kits.
Healthcare professionals using the recalled Datascope Intra-Aortic Balloon Catheter kits in Japan are most at risk. Patients receiving these kits during medical procedures may be affected.
Check for the product name 'Datascope Intra-Aortic Balloon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 40cc IAB (Japan) Kit' with the specific lot numbers listed in the recall notice.
Reach out to Datascope Corporation for specific instructions on how to handle the recalled kits.
The recalled kits may contain endotoxins, which can cause infections or adverse reactions during medical procedures.
The affected lot numbers are listed in the recall notice: 3000045568, 3000047929, 3000047928, and other specific numbers.
The recall does not specify an immediate stop-use action; contact Datascope for guidance.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-2844-2020 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-2844-2020 from Datascope. 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.
