Angiodynamics recalls TANDEM 5F DL BIOFLO PASV kits due to potential unsafe bacterial endotoxins. Affected units may pose health risks; contact for details.
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
Angiodynamics is recalling TANDEM 5 kits that might contain unsafe levels of bacterial endotoxins. This could cause health issues if used improperly. Affected customers should check their product details and follow the recall instructions.
The kits might contain unsafe levels of bacterial endotoxins (pyrogens), which can cause fever or other health issues if the product is used. This risk is related to the product's medical use, not typical consumer use.
Patients using TANDEM 5F DL BIOF: 5F DL BIOFLO PASV kits for medical procedures. Those with specific medical conditions may be at higher risk.
Check for the catalog number 60M140567 or lot number 5316349 on the TANDEM 5F DL BIOFLO PASV kit. The product was sold under the brand Angiodynamics.
Look for catalog number 60M140567 or lot number 5316349 on the TANDEM 5F DL BIOFLO PASV kit.
The recall states that the kits might contain unsafe levels of bacterial endotoxins, so they should not be used until the recall is addressed.
Check for catalog number 60M140567 or lot number 5316349 on the TANDEM 5F DL BIOFLO PASV kit.
The recall does not specify a remedy, so contact Angiodynamics for further instructions.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-2206-2018 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-2206-2018 from Angiodynamics. 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.
