FDAClass IIApril 7, 2021

AngioDynamics SafeSheath ULTRALITE 10F recall

AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads and…

Why was AngioDynamics SafeSheath ULTRALITE 10F recalled?

Potential for open seal on sterile product

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

GUDID: 25051684026298; Lot Number DP-11759

Product
AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads and…
Recalling firm
Oscor, Inc.
Quantity
500 devices
Distribution
US Nationwide distribution in the state of New York.
Recall date
April 7, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls