Datascope recalls specific YAMATO PLUS-R 7.5Fr 40cc 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 40cc 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 infections or adverse reactions when introduced into the body. In medical procedures, these contaminants could lead to complications if the catheters are used improperly.
Medical 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 if your kit has the lot numbers listed: 3000053317, 3000056694, 3000057318, 3000057970, 3000062073, 3000062639, 3000062640, 3000068106, 3000071287, 3000072717, 3000064723, 3000072718, 3000072719, 3000074886, 3000087744, 3000090528, 3000076632, 3000078856, 3000080307, 3000083331, 3000084962, 3000092774, 3000092775, 3000095473, 3000096376, 3000096606, 3000096379, 3000098751, 3000104521, 3000115011. The product is a medical kit sold in Japan.
Verify if your kit has any of the listed lot numbers: 3000053317, 3000056694, 3000057318, 3000057970, 3000062073, 3000062639, 3000062640, 3000068106, 3000071287, 3000072717, 3000064723, 3000072718, 3000072719, 3000074886, 3000087744, 3000090528, 3000076632, 3000078856, 3000080307, 3000083331, 3000084962, 3000092774, 3000092775, 3000095473, 3000096376, 3000096606, 3000096379, 3000098751, 3000104521, 3000115011.
The recalled catheters may contain endotoxins, which are bacterial components that could cause infections or adverse reactions during medical procedures.
Check if your kit has any of the listed lot numbers: 3000053317, 3000056694, 3000057318, 3000057970, 3000062073, 3000062639, 3000062640, 3000068106, 3000071287, 3000072717, 3000064723, 3000072718, 3000072719, 3000074886, 3000087744, 3000090528, 3000076632, 3000078856, 3000080307, 3000083331, 3000084962, 3000092774, 3000092775, 3000095473, 3000096376, 3000096606, 3000096379, 3000098751, 3000104521, 3000115011.
Contact Datascope Corporation for instructions on how to handle the kit. The recall does not specify a specific action beyond checking the lot numbers.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-2847-2020 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-2847-2020 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.
