FDAFDA · Food and drugs·Recall number Z-1467-2021
AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For the introduction of various types of pacing leads and catheters.
Published April 28, 2021 · Recall initiated: February 22, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Distributor
- 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.
- Lot
- UPN: VI10, Lot #: DP-11759
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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