PlainRecalls
FDA Devices Moderate Class II Terminated

Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 cm .035 NB PG; Catalog Number: 10732201 AngioDynamics Angiographic Catheters are for use where angiographic diagnosis is indicated.

Reported: March 7, 2018 Initiated: September 22, 2017 #Z-0742-2018

Product Description

Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 cm .035 NB PG; Catalog Number: 10732201 AngioDynamics Angiographic Catheters are for use where angiographic diagnosis is indicated.

Reason for Recall

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

Details

Recalling Firm
Angiodynamics, Inc.
Units Affected
28
Distribution
US Distribution to the states of : AL, CA, CT, FL, GA, IL, IN, MD, MI, MN, MO, OH, OR, TX.
Location
Queensbury, NY

Frequently Asked Questions

What product was recalled?
Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 cm .035 NB PG; Catalog Number: 10732201 AngioDynamics Angiographic Catheters are for use where angiographic diagnosis is indicated.. Recalled by Angiodynamics, Inc.. Units affected: 28.
Why was this product recalled?
Product was placed into distribution prior to completion of all required post sterilization release activities.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 7, 2018. Severity: Moderate. Recall number: Z-0742-2018.