Datascope recalls specific Trans-Ray 7Fr 34cc IAB kits (Japan) due to potential endotoxin contamination. Affected kits have listed lot numbers. Users should contact Datascope for details.
Potential Endotoxin Contamination
Datascope is recalling certain Trans-Ray 7Fr 34cc IAB 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 or reactions when introduced into the body. In medical procedures, this contamination could lead to serious health complications.
Medical professionals using the recalled Trans-Ray 7Fr 34cc IAB kits in Japan are most at risk. Patients undergoing procedures with these kits could be affected.
Check the kit's lot number against the list: 3000066986, 3000069732, 3000077731, 3000077732, 3000080305, 3000083332, 3000083333, 3000084968, 3000087492, 3000095469, 3000096180, 3000096181, 3000096585, 3000098052, 3000103498, 3000104616, 3000104617, 3000112275, 3000113067. The kits are used in Japan for cardiac and non-cardiac surgeries.
Compare your kit's lot number with the list provided in the recall: 3000066986, 3000069732, 3000077731, 3000077732, 3000080305, 3000083332, 3000083333, 3000084968, 3000087492, 3000095469, 3000096180, 3000096181, 3000096585, 3000098052, 3000103498, 3000104616, 3000104617, 3000112275, 3000113067.
The kits may contain endotoxins, which are bacterial components that could cause serious infections or reactions during medical procedures.
Lot numbers 3000066986, 3000069732, 3000077731, 3000077732, 3000080305, 3000083332, 3000083333, 3000084968, 3000087492, 3000095469, 3000096180, 3000096181, 3000096585, 3000098052, 3000103498, 3000104616, 3000104617, 3000112275, 3000113067.
The recall does not specify a remedy, so there is no instruction to stop using or discard the kits. Check the lot number to see if it is affected.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-2841-2020 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-2841-2020 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.
