Device product
Multi-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, CS-15853-E Product CVCs are intended to permit venous access to the central circulation through a single puncture site by way of the femoral, jugular, or subclavian veins.
Z-2336-2018
Product summary
- Event
- Event 80227
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1200
- Official record key
device-enforcement:Z-2336-2018
Official wording
Reason: The recalling firm has received complaints related to increased resistance encountered when introducing the CVC over the spring wire guide. This may lead to procedural delay, and there may be need of medical intervention by exchanging the catheter for another CVC catheter.
Code information: 71F18A0682
Distribution pattern: Distributor in FL. International distribution to Czech Republic, Dominican Republic, France, Greece, and Italy.
Derived failure modes
-
Unknown
The recalling firm has received complaints related to increased resistance encountered when introducing the CVC over the spring wire guide. This may lead to procedural delay, and there may be need of medical intervention by exchanging the catheter for another CVC catheter.