Datascope recalls Japan-sold TRANS-RAY PLUS 7.5Fr 35cc IAB kits with potential endotoxin contamination. Affected kits have specific lot numbers. Users should contact Datascope for details.
Potential Endotoxin Contamination
Datascope is recalling certain TRANS-RAY PLUS 7.5Fr 35cc IAB kits sold in Japan due to potential endotoxin contamination. This could pose a health risk during medical procedures, so affected users should contact Datascope for instructions.
Endotoxins are toxic substances found in the outer membrane of bacteria. If present in medical devices like IABs, they could cause infections or adverse reactions during procedures. The recall indicates possible contamination in specific kits.
Healthcare professionals using the recalled IAB kits in Japan are most at risk. Patients receiving these kits during procedures may be affected if the contamination occurs.
Check for the product name 'TRANS-RAY PLUS 7.5Fr 35cc IAB (Japan) Kit' with lot numbers listed in the recall (e.g., 3000047804, 3000053322).
Reach out to Datascope Corporation for specific instructions on how to handle the recalled kit.
The kits may contain endotoxins, which are bacterial toxins that could cause infections or adverse reactions during medical procedures.
Affected lot numbers include 3000047804, 3000053322, 3000053323, and others listed in the recall.
Check for the product name 'TRANS-RAY PLUS 7.5Fr 35cc IAB (Japan) Kit' with lot numbers from the list provided in the recall.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-2843-2020 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-2843-2020 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.
