Angiodynamics recalls 5F Micro-Introducer Kits that may include a 4F Sheath/Dilator component, which could cause incorrect device use during vascular procedures.
5F Micro-Introducer Kits may not contain the correct device, packaged with a 4F Sheath/Dilator component
Angiodynamics is recalling its 5F Standard Micro-Introducer Kits because some kits may contain a 4F Sheath/Dilator component instead of the correct 5F device. This mismatch could lead to improper use during vascular procedures, potentially causing complications.
The 5F Micro-Introducer Kit is designed for percutaneous vascular procedures but may be packaged with a 4F Sheath/Dilator component. Using a 4F component with a 5F kit could cause incorrect device sizing, potentially leading to complications during procedures.
Healthcare professionals using the Angiodynamics 5F Micro-Introducer Kits for vascular procedures are most at risk if they receive a kit with the incorrect 4F Sheath/Dilator component.
Check the kit's catalog number (06597035) and lot number (5626935) on the packaging. The kit was sold between 2020 and 2023 with an expiration date of 08/31/2023.
Look for the catalog number 06597035 and lot number 5626935 on the kit's packaging.
The recall is because some 5F Micro-Introducer Kits may contain a 4F Sheath/Dilator component instead of the correct 5F device, which could cause incorrect sizing during vascular procedures.
Check the kit's catalog number (06597035) and lot number (5626935) on the packaging. The kit was sold between 2020 and 2023 with an expiration date of 08/31/2023.
The recall record does not specify a remedy, so no action is required beyond checking the kit's packaging for the catalog and lot numbers.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-0418-2021 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-0418-2021 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.
