FDAClass IIMarch 7, 2018

Soft-Vu Omni Flush Angiographic Catheter recall

Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 cm .035 NB PG; Catalog Number: 10732201 AngioDynamics Angiographic…

Why was Soft-Vu Omni Flush Angiographic Catheter recalled?

Product was placed into distribution prior to completion of all required post sterilization release activities.

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?

Lot Number: 5229642; Manufactured 6-Sep-17; Expiration Date: 31-Aug-20

Product
Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 cm .035 NB PG; Catalog Number: 10732201 AngioDynamics Angiographic…
Recalling firm
Angiodynamics, Inc.
Quantity
28
Distribution
US Distribution to the states of : AL, CA, CT, FL, GA, IL, IN, MD, MI, MN, MO, OH, OR, TX.
Recall date
March 7, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls