Device product
ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The Multiple-Lumen Catheter permits venous access to the central circulation by way of the femoral jugular, or subclavian veins.
Z-1082-2015
Product summary
- Event
- Event 70175
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1195
- Official record key
device-enforcement:Z-1082-2015
Official wording
Reason: Foreign material found within the kits. The foreign material, white or black particles and/or thread, is visible and can beidentified by the user.
Code information: product number CDC-42802-P1A, lot number 23F14A0063
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Foreign material