Datascope recalls Sensation Plus 7.5 Fr 40cc IAB kits with potential endotoxin contamination. Affected kits include specific model numbers and lot numbers. Consumers should contact Datascope for details.
Potential Endotoxin Contamination
Datascope is recalling Sensation Plus 7.5 Fr 40cc IAB kits due to potential endotoxin contamination. This could cause infections or other health issues if used in medical procedures. Affected kits have specific model 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, they can cause infections or adverse reactions in patients during procedures. The specific contamination risk in these kits is not fully detailed in the recall notice.
Medical professionals using the Sensation Plus IAB kits for cardiac procedures are most at risk. Patients undergoing these procedures with the recalled kits could be affected if the contamination occurs.
Check for model numbers 0684-00-0568-01, 0684-00-0568-01U, 0684-00-0568-05, or 0684-00-0568-09 on the kit packaging. Also look for lot numbers 3000102215 through 3000111682 as listed in the recall.
Reach out to Datascope Corporation for specific instructions on how to handle the recalled kits.
The recall states there is a potential for endotoxin contamination in the kits, which could lead to infections or adverse reactions during medical procedures. The exact risk level is not specified in the notice.
The affected kits have model numbers 0684-00-0568-01, 0684-00-0568-01U, 0684-00-0568-05, or 0684-00-0568-09 with specific lot numbers listed in the recall notice.
Check the model number and lot number on your kit packaging against the list 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-2836-2020 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-2836-2020 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.
