Recall Z-0418-2021— Angiodynamics, Inc.
Class II · Terminated
Class II FDA medical device recall by Angiodynamics, Inc., initiated 2020-10-14, terminated 2021-10-19. It names one FDA 510(k) clearance: K051655. Product: Angiodynamics 5F Standard Micro-Introducer Kit - indicated for percutaneous introduction of a guidewire or catheter into the vascular system, Catalog Number: 06597035 UPN: H787065970355. Reason: 5F Micro-Introducer Kits may not contain the correct device, packaged with a 4F Sheath/Dilator component.
- Recalling firm
- Angiodynamics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-10-14
- Terminated
- 2021-10-19
- 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
Angiodynamics 5F Standard Micro-Introducer Kit - indicated for percutaneous introduction of a guidewire or catheter into the vascular system, Catalog Number: 06597035 UPN: H787065970355
Reason for recall
5F Micro-Introducer Kits may not contain the correct device, packaged with a 4F Sheath/Dilator component
Data sourced from openFDA. This site is unofficial and independent of the FDA.