Datascope recalls Sensation Plus 8Fr 50cc IAB kits with potential endotoxin contamination. Affected kits include specific part numbers and lot numbers. Consumers should contact Datascope for details.
Potential Endotoxin Contamination
Datascope is recalling Sensation Plus 8Fr 50cc IAB kits due to potential endotoxin contamination. This could cause infections or other health issues if used in medical procedures. Affected kits have specific part numbers and lot numbers listed in the recall.
Endotoxins are toxic substances found in the outer layer of certain bacteria. If present in medical devices like IAB kits, they could cause infections or adverse reactions during procedures. The recall indicates a potential contamination risk in specific kits.
Medical professionals using the Sensation Plus 8Fr 50cc IAB kits for cardiac procedures are most at risk. Patients undergoing these procedures may be affected if the contaminated kits are used.
Check for part numbers 0684-00-0576-01, 0684-00-0576-01U, 0684-00-0576-05, or 0684-00-0576-09 on the kit packaging. Also, verify if your kit has lot numbers from the list provided in the recall notice.
Reach out to Datascope Corporation for specific information about your kit and instructions on next steps.
The recall states there is a potential for endotoxin contamination, which could lead to infections or adverse reactions during medical procedures.
Affected kits have part numbers 0684-00-0576-01, 0684-00-0576-01U, 0684-00-0576-05, or 0684-00-0576-09 with specific lot numbers listed in the recall.
Check the part number on your kit packaging and compare it to the listed part numbers. Also, verify the lot number against the provided list.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-2837-2020 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-2837-2020 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.
