Device product
Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters. Permits venous access and catheter introduction to the central circulation.
Z-1158-2018
Product summary
- Event
- Event 79342
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18,124 total
- Official record key
device-enforcement:Z-1158-2018
Official wording
Reason: Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions.
Code information: ASK-09903-ECL 23F16H0387 23F16H0595
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions.