Skip to content
Recall Observatory FDA recall evidence

Device 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.

Z-0742-2018

September 22, 2017

Class II

Product summary

Firm
Angiodynamics, Inc.
Event
Event 79193
Status
Terminated
Classification
Class II
Quantity
28
Official record key
device-enforcement:Z-0742-2018

Official wording

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

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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