Datascope recalls Sensation 7Fr 40cc 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 certain Sensation 7Fr 40cc IAB kits due to potential endotoxin contamination. This could pose a health risk if the catheters are used in medical procedures.
Endotoxins are bacterial components that can cause severe infections or allergic reactions when introduced into the bloodstream during medical procedures. The contamination in these kits could lead to serious health complications if used improperly.
Healthcare professionals using the recalled kits for cardiac procedures are most at risk. Patients undergoing acute coronary syndrome or heart failure treatments may be affected if the kits are used.
Check for part numbers 0684-00-0470-01, 0684-00-0470-01U, 0684-00-0470-07, or 0684-00-0470-09. Also look for lot numbers listed in the recall notice.
Reach out to Datascope Corporation for specific instructions on how to handle the recalled kits.
The recall is due to potential endotoxin contamination in the kits, which could cause serious health issues during medical procedures.
Contact Datascope Corporation directly for instructions on how to handle the recalled kits.
Yes, the recall includes specific lot numbers listed in the notice, such as 3000046316 and others.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-2835-2020 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-2835-2020 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.
