Datascope recalls Sensation 7Fr 34cc IAB kits with potential endotoxin contamination. Affected kits have specific part numbers and lot numbers. Consumers should contact Datascope for details.
Potential Endotoxin Contamination
Datascope is recalling Sensation 7Fr 34cc 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 membrane of certain bacteria. If present in medical devices like IAB kits, they can cause infections or adverse reactions when used during procedures. The specific contamination risk is not detailed in the recall notice.
Healthcare professionals using the Sensation 7Fr 34cc IAB kits for cardiac procedures are most at risk. Patients undergoing these procedures with affected kits may face infection or complications.
Check for part numbers 0684-00-0469-01, 0684-00-0469-01C, or 0684-00-0469-01U in the kit. Also look for lot numbers listed in the recall notice, such as 3000045657.
Reach out to Datascope Corporation for specific instructions on how to handle affected kits.
The recall states there is potential endotoxin contamination, which could cause infections or adverse reactions during medical procedures. The exact risk level is not specified in the notice.
Affected kits have part numbers 0684-00-0469-01, 0684-00-0469-01C, or 0684-00-0469-01U, and specific lot numbers listed in the recall notice.
Check the part number on your kit and compare it to the listed part numbers (0684-00-0469-01, 0684-00-0469-01C, 0684-00-0469-01U) and lot numbers provided in the recall.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-2834-2020 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-2834-2020 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.
