FDA-Device2021-04-28Class II
AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For the introduction of various types of pacing leads and catheters.
Angiodynamics Inc. (Navilyst Medical Inc.)
Hazard
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.
Sold states
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.
Affected count
337 units, (14 boxes of 5, 267 units each kit)
Manufactured in
10 Glens Falls Tech Park, N/A, Glens Falls, NY, United States
Products
AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For the introduction of various types of pacing leads and catheters.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1467-2021Don't want to check this manually?
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