Angiodynamics recalls BioFlo PICCs with incorrect expiration dates that could expire beyond validated shelf life. Affected units may need removal to prevent use beyond tested safety limits.
specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with incorrect expiration dates. The labelled expiration date extends the shelf life of the product beyond the date supported by validation testing. Although the product under recall has not yet reached its validated expiry date, removal of the affected product is warranted to prevent use beyond the validated expiry date.
Angiodynamics is recalling BioFlo PICCs with ENDEXO and PASV that have incorrect expiration dates. Using these products beyond their validated shelf life could lead to safety issues.
The recalled BioFlo PICCs show expiration dates that extend beyond the product's validated shelf life. This means the product might not be safe for use after the validated expiration date, though it hasn't yet reached that date.
Healthcare providers using these specific BioFlo PICCs for patients. Patients receiving care from facilities that use the recalled models are most at risk.
Check for the model number 60M183481 or 5231609 on the BioFlo PICC with ENDEXO and PASV. The product was sold through Memorial Hospital System (LTP) PG.
Verify the expiration date on the BioFlo PICC label to ensure it matches the validated shelf life.
The BioFlo PICCs have incorrect expiration dates that extend beyond the validated shelf life, so removal is recommended to prevent use beyond safe limits.
The product has not yet reached its validated expiration date, so it is not currently dangerous but should be removed to prevent future issues.
Look for the model numbers 60M183481 or 5231609 on the BioFlo PICC with ENDEXO and PASV, which was sold through Memorial Hospital System (LTP) PG.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-0596-2019 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-0596-2019 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.
