Recall Z-0742-2018— Angiodynamics, Inc.
Class II · Terminated
Class II FDA medical device recall by Angiodynamics, Inc., initiated 2017-09-22, terminated 2018-09-19. It names one FDA 510(k) clearance: K112452. 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: Product was placed into distribution prior to completion of all required post sterilization release activities..
- Recalling firm
- Angiodynamics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-09-22
- Terminated
- 2018-09-19
- Firm location
- Queensbury, NY, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.