medical Class II Updated 2021-04-28

Angiodynamics Inc. (Navilyst Medical Inc.) recalls AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Ca

Recalled Product

AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For the introduction of various types of pacing leads and catheters.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UPN: VI10, Lot #: DP-11759
View official government recall

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