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.
Reported: July 11, 2018 Initiated: May 11, 2018 #Z-2336-2018
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.
Details
- Recalling Firm
- Arrow International Inc
- Units Affected
- 1200
- Distribution
- Distributor in FL. International distribution to Czech Republic, Dominican Republic, France, Greece, and Italy.
- Location
- Reading, PA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Arrow International Inc. Units affected: 1200.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 11, 2018. Severity: Moderate. Recall number: Z-2336-2018.
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