Recall Z-1467-2021 ยท DYB Introducer, Catheter
Angiodynamics Inc. (Navilyst Medical Inc.)
AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For the introduction of various types of pacing leads and catheters.
| Date | Feb 22, 2021 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 337 units, (14 boxes of 5, 267 units each kit) |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122084 | INTRODUCER SET, MODEL ADELANTE-S SERIES Oscor, Inc., Aug 29, 2012 |