Datascope recalls specific YAMATO PLUS-R 7.5Fr 30cc IAB kits (Japan) due to potential endotoxin contamination. Affected kits have listed lot numbers. Contact Datascope for details.
Potential Endotoxin Contamination
Datascope is recalling certain YAMATO PLUS-R 7.5Fr 30cc IAB catheter kits from Japan because they may contain endotoxins. This could pose a health risk during medical procedures. Affected kits have specific lot numbers listed in the recall.
Endotoxins are bacterial components that can cause severe infections if introduced into the bloodstream during medical procedures. The potential contamination in these specific kits could lead to serious health complications for patients.
Medical professionals using the recalled catheter kits in Japan are most at risk. Patients undergoing cardiac or heart failure procedures with these kits could be affected.
Check if your kit has the model name 'YAMATO PLUS-R 7.5Fr 30cc IAB' and the listed lot numbers from the recall. The product was sold in Japan.
Look for the lot numbers listed in the recall (e.g., 3000045349) on your kit's packaging.
The recall states potential endotoxin contamination, which could cause serious infections during medical procedures.
Check if your kit has the model name 'YAMATO PLUS-R 7.5Fr 30cc IAB' and one of the listed lot numbers (e.g., 3000045349).
The recall does not specify a stop-use instruction, so you should check the lot numbers and contact Datascope if needed.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-2845-2020 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-2845-2020 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.
