Z-2336-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 11, 2018
- Initiation Date
- May 11, 2018
- Termination Date
- April 20, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1200
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Distributor in FL. International distribution to Czech Republic, Dominican Republic, France, Greece, and Italy.
Code Information
71F18A0682