Datascope recalls specific Trans-Ray 7Fr 40cc IAB catheters (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 40cc IAB catheters sold in Japan because they may contain endotoxins. This could pose a health risk during medical procedures. Affected users should check their kit lot numbers and contact Datascope for instructions.
Endotoxins are bacterial components that can cause severe infections or sepsis when introduced into the bloodstream. In medical procedures, contaminated catheters could lead to life-threatening infections if used in cardiac surgeries.
Medical professionals using these catheters for cardiac procedures in Japan are most at risk. Patients receiving these devices during surgery may be affected if the catheters are contaminated.
Check your kit's lot number against the list: 3000051381, 3000053316, 3000057969, and other numbers listed in the recall notice. These catheters were sold in Japan for cardiac procedures.
Compare your kit's lot number with the list provided in the recall notice to determine if it is affected.
The recall states potential endotoxin contamination, so affected kits should not be used until Datascope provides instructions.
Contact Datascope directly using the information provided in the recall notice to get specific instructions.
Check your kit's lot number against the list of numbers provided in the recall notice.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-2842-2020 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-2842-2020 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
