Z-1467-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 28, 2021
- Initiation Date
- February 22, 2021
- Termination Date
- July 19, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 337 units, (14 boxes of 5, 267 units each kit)
Product Description
AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For the introduction of various types of pacing leads and catheters.
Reason for Recall
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.
Distribution Pattern
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.
Code Information
UPN: VI10, Lot #: DP-11759