Angiodynamics recalls Xcela Power PICC kits with incorrect expiration dates that could lead to use beyond validated shelf life. Affected kits may need replacement to ensure safety.
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 recalls Xcela Power Injectable PICC kits with incorrect expiration dates. Using these kits beyond their validated shelf life could pose risks, so affected users should replace them.
The kits have labels with expiration dates that extend beyond the validated shelf life. Using them after this date could lead to issues with the product's safety and effectiveness.
Patients using the Xcela Power PICC kits with incorrect expiration dates. Healthcare providers who administered these kits are most at risk.
Check for the Xcela Power PICC kit with model XCELA PASV 4F SL 55CM Catheter Kit CE PG, lot number 5096448. The product was sold with incorrect expiration dates.
Verify the lot number on the kit label to confirm if it matches the affected lot 5096448.
The kits have labels with expiration dates that extend beyond the validated shelf life, so they could be used beyond safe limits.
The official recall notice does not specify a remedy, so check with Angiodynamics for guidance.
The recall states the product has not yet reached its validated expiry date, so the risk is low.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-0595-2019 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-0595-2019 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.
