Z-0179-2018 Class II Terminated
FDA device recall Z-0179-2018 was initiated by Arrow International Inc on June 1, 2017 and is designated Class II. Reason for recall: There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths. The recall status is terminated (terminated April 13, 2020). Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- December 6, 2017
- Initiation Date
- June 1, 2017
- Termination Date
- April 13, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market available peripherally inserted central catheters (PICCs) to the goal location which is to the cavo-atrial junction near the sino-atrial node
Reason for Recall
There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.
Distribution Pattern
Nationwide Distribution to AZ, CA, MA, MO, NC, NY, OR & SD
Code Information
Lot/Batch Numbers: 23F16M0017