FDA recall Z-0742-2018

Product

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.

Distribution

US Distribution to the states of : AL, CA, CT, FL, GA, IL, IN, MD, MI, MN, MO, OH, OR, TX.

Key facts

Status

Terminated

Initiation date

2017-09-22

Report date

2018-03-07

Termination date

2018-09-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Queensbury, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0742-2018