AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For the introduction of various types of pacing leads and catheters.
Recall
- Recall Number
- Z-1467-2021
- Event Number
- 87567
- Firm
- Angiodynamics Inc. (Navilyst Medical Inc.)
- FEI Number
- 3017892510
- Product Code
- DYB
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- February 22, 2021
- Terminated
- July 19, 2022
- Address
- 10 Glens Falls, Tech Park Glens Falls, NY, 12801-3864
Description
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. 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.
On 2/22/2021, AngioDynamics issued an Urgent Medical Device Recall notice via letter informing customers the package integrity of specific Valved Introducers may be susceptible to failure, resulting in the potential for compromised sterility of the device.
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.
337 units, (14 boxes of 5, 267 units each kit)