Device product
ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media and allows for central venous pressure monitoring
Z-0181-2018
Product summary
- Event
- Event 77589
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-0181-2018
Official wording
Reason: There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.
Code information: Lot/Batch Number: 23F16K0055
Distribution pattern: Nationwide Distribution to AZ, CA, MA, MO, NC, NY, OR & SD
Derived failure modes
-
Unknown
There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.