Device 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
Z-0418-2021
Product summary
- Event
- Event 86627
- Status
- Terminated
- Classification
- Class II
- Quantity
- 32 kits
- Official record key
device-enforcement:Z-0418-2021
Official wording
Reason: 5F Micro-Introducer Kits may not contain the correct device, packaged with a 4F Sheath/Dilator component
Code information: Lot Number: 5626935 Expiration Date: 08/31/2023
Distribution pattern: US Nationwide distribution including in the states of AL, CT, GA, FL.
Derived failure modes
-
Unknown
5F Micro-Introducer Kits may not contain the correct device, packaged with a 4F Sheath/Dilator component