Z-1160-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 28, 2018
- Initiation Date
- November 14, 2017
- Termination Date
- July 15, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18,124 total
Product Description
Percutaneous Sheath Introducer Kit with ARROWg+ard Blue Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters. Permits venous access and catheter introduction to the central circulation.
Reason for Recall
Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions.
Distribution Pattern
Nationwide Distribution
Code Information
ASK-29803-SJH 13F16K0136