Z-2332-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 21, 2017
- Initiation Date
- May 9, 2017
- Termination Date
- September 17, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 27,485 units distributed in U.S., 4,371 units distributed internationally
Product Description
Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features. 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. Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for Recall
Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
Distribution Pattern
Worldwide Distribution - US (nationwide) and Canada
Code Information
Material number: ASK-45703-AH, CDC-42703-1A, CDC-42703-1A, CDC-42854-1A, CDC-45703-1A, CDC-45703-A1A, CDC-45703-B1A, CDC-45854-1A, CDC-47702-1A Device Listing D213817