Z-1165-2018 Class II Terminated
FDA device recall Z-1165-2018 was initiated by Arrow International Inc on November 14, 2017 and is designated Class II. 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 … The recall status is terminated (terminated July 15, 2019). Affected quantity: 18,124 total.
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
Pressure Injectable Multi- Lumen CVC Kit
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
CDC-15703-P1A 13F16J0336