Angiodynamics recalls Xcela PICC with PASV Valve Kit 5F-55cm due to mislabeling as 5F when it's actually 4F. This could lead to incorrect use in medical procedures.
Mislabeled: The product is labeled as 5F (55cm; Maximum Flow Rate 3.5 mL/Sec) and the product is actually 4F (55cm; Maximum Flow Rate 3.5 mL/Sec).
Angiodynamics is recalling Xcela PICC lines with PASV Valve Technology that are mislabeled as 5F (55cm) when they are actually 4F. This mislabeling could lead to improper use in medical procedures if the wrong size is used.
The product is labeled as 5F (55cm; Maximum Flow Rate 3.5 mL/Sec) but is actually 4F (55cm; Maximum Flow Rate 3.5 mL/Sec). This mislabeling could lead to incorrect use in medical procedures if the wrong size is used, potentially causing complications.
Patients using this specific PICC line for intravenous therapy may be affected if they receive the mislabeled product. Healthcare providers who use these devices for medical procedures are most at risk.
Check the product label for the size designation (5F or 4F) and the catalog number (60M701995) and lot number (5210162). The UDI code is H96560M7019951.
Look for the size designation (5F or 4F) and catalog number (60M701995) on the product label.
The product is mislabeled as 5F when it is actually 4F, which could lead to incorrect use in medical procedures.
The recall record does not specify a remedy, so check the product label to confirm the size designation and contact the manufacturer for further instructions.
Check the product label for the size designation (5F or 4F) and catalog number (60M701995). The lot number is 5210162 and UDI code is H96560M7019951.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-2617-2021 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-2617-2021 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.
