Recall Z-1467-2021— Angiodynamics Inc. (Navilyst Medical Inc.)

Name: FDA recall Z-1467-2021
Creator: U.S. Food and Drug Administration
Published: 2021-02-22

Class II · Terminated

Class II FDA medical device recall by Angiodynamics Inc. (Navilyst Medical Inc.), initiated 2021-02-22, terminated 2022-07-19. It names one FDA 510(k) clearance: K122084. Product: AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For the introduction of various types of pacing leads and catheters.. 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..

Recalling firm: Angiodynamics Inc. (Navilyst Medical Inc.)
Classification: Class II
Status: Terminated
Initiated: 2021-02-22
Terminated: 2022-07-19
Firm location: Glens Falls, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K122084 — INTRODUCER SET, MODEL ADELANTE-S SERIESOscor, Inc.·cleared 2012-08-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.