FDA-Device2018-07-11Class II
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.
Arrow International Inc
Hazard
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.
Sold states
Distributor in FL. International distribution to Czech Republic, Dominican Republic, France, Greece, and Italy.
Affected count
1200
Manufactured in
2400 Bernville Rd, Reading, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2336-2018Don't want to check this manually?
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