Device product
ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO; Rx ONLY - Product Usage: Introducer Products are stand-alone components, standard kits, or convenience kits built to user specifications. These products facilitate access to a vein or artery, allowing various catheters to be passed through for local or central diagnostic or therapeutic interventions. Indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
Z-2806-2020
Product summary
- Event
- Event 86036
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1000 units
- Official record key
device-enforcement:Z-2806-2020
Official wording
Reason: Sterile introducer sheath set manufactured under one lot with different expiration dates.
Code information: LOT 11295042
Distribution pattern: US Nationwide distribution including in the state of MS.
Derived failure modes
-
Unknown
Sterile introducer sheath set manufactured under one lot with different expiration dates.