Z-0468-2019 Class II Terminated
FDA device recall Z-0468-2019 was initiated by Arrow International Inc on Sep 21, 2018 and is designated Class II. Reason for recall: The products labeling contains inconsistencies. In certain instances, the lidstock, banner card and shipper label state that the Spring Wire Guide (SWG) within is .032 rather than the correct SWG… The recall status is terminated (terminated Sep 23, 2020). Affected quantity: 3640.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 21, 2018
- Initiation Date
- Sep 21, 2018
- Termination Date
- Sep 23, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3640
Product Description
Arrow AGB+ Multi-Lumen CVC Kit, 7 Fr., 3 Lumen, 20cm catheter length, .025 inch dia. spring-wire guide, Product Code CDC-45703-B1A - Product Usage: The multiple-lumen catheter permits venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. The ARROWg+ard Blue Plus antimicrobial catheter is intended to help provide protection against catheter-related infections. It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use.
Reason for Recall
The products labeling contains inconsistencies. In certain instances, the lidstock, banner card and shipper label state that the Spring Wire Guide (SWG) within is .032 rather than the correct SWG size .025 . For other lots in scope the lidstock correctly states the SWG size .025 however the banner card states the incorrect SWG size .032 .
Distribution Pattern
US Nationwide distribution in the states of CA, FL, ID, IL, MI, NC, NJ, PA, and WI.
Code Information
Lot/Batch Numbers: 13F17E0685 13F17F0562 13F17H0141 13F17K0340 13F18B0119 13R17E0685
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0468-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026