Angiodynamics Inc. (Navilyst Medical Inc.) Recall 87567
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. (Navilyst Medical Inc.) Recall 87567 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1467-2021 |
| Event ID | 87567 |
| Event Description | AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For the introduction of various types of pacing leads and catheters. |
| Product Type | Devices |
| 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. |
| Quantity | 337 units, (14 boxes of 5, 267 units each kit) |
| Recall 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. |
| Device Classification | 20210428 |
| Device Code Info | UPN: VI10, Lot #: DP-11759 |
| Center Classification Date | 20210421 |
| Recall Initiation Date | 20210222 |
| Recalling Firm | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Initial Notification | Letter |
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