FDA recall Z-2336-2018

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.

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

Distributor in FL. International distribution to Czech Republic, Dominican Republic, France, Greece, and Italy.

Key facts

Status

Terminated

Initiation date

2018-05-11

Report date

2018-07-11

Termination date

2020-04-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Reading, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2336-2018