Datascope recalls specific 7.5Fr 25cc IAB kits due to potential endotoxin contamination. Affected kits include model numbers 0684-00-0478-01 and variants. Consumers should check lot numbers for affected units.
Potential Endotoxin Contamination
Datascope is recalling certain 7.5Fr 25cc Intra-Aortic Balloon Catheter (IAB) kits because they may contain endotoxins. This could pose a risk of infection or other complications during medical procedures. Patients using these kits should contact Datascope for guidance.
Endotoxins are bacterial components that can cause infections when introduced into the bloodstream. In medical procedures, these contaminants could lead to serious infections if the kits are used improperly.
Healthcare professionals and patients using the recalled IAB kits for cardiac procedures. Those with the specific model numbers and lot numbers listed are most at risk.
Check for model numbers 0684-00-0478-01, 0684-00-0478-01C, 0684-00-0478-01U, 0684-00-0478-02, or 0684-00-0478-02U. Also look for lot numbers from the list provided in the recall notice.
Compare your kit's model number and lot number against the list provided in the recall notice to determine if it is affected.
The recalled kits have model numbers 0684-00-0478-01, 0684-00-0478-01C, 0684-00-0478-01U, 0684-00-0478-02, or 0684-00-0478-02U.
Affected lot numbers include 3000049797, 3000053552, 3000056193, and other numbers listed in the recall notice.
Check your kit's model number and lot number against the specific 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-2838-2020 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-2838-2020 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.
