Angiodynamics Inc. (Navilyst Medical Inc.) recalls AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For th…

Recall date

February 22, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1467-2021

FDA classification

Class II

Brand / firm

Angiodynamics Inc. (Navilyst Medical Inc.)

Sold / distributed

US Nationwide distribution in the states of AR, CA, CO, FL, HI, IL, IN, KS, MI, MO, NC, ND, NM, NY, OH, OR, PA, SC, TN, TX, VA, WA.

Why it was recalled

AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits and Valved introducers that may have potential for compromised sterility of the device. Only the specific product/lot of the kit identified below is affected by this recall action. The Product Description, Product Number, Ref./Catalog Number and Batch/Lot number is provided below. No other products are affected by this recall.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For the introduction of various types of pacing leads and catheters.