Z-2336-2018 Class II Terminated
FDA device recall Z-2336-2018 was initiated by Arrow International Inc on May 11, 2018 and is designated Class II. 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… The recall status is terminated (terminated Apr 20, 2020). Affected quantity: 1200.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 11, 2018
- Initiation Date
- May 11, 2018
- Termination Date
- Apr 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2336-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026