Z-1699-2021 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 9, 2021
- Initiation Date
- February 11, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 292 devices
Product Description
NexSite HD, Hemodialysis Symmetric Tip Catheter for long term use
Reason for Recall
The action is to ensure consistency between the Directions for Use (DFU) in the field and the DFU on the website.
Distribution Pattern
U.S.: CO, NC, SC, TX, O.U.S.: Not provided
Code Information
Model Number/Product Description/Lot Number: NEXHDSY1551901/NexSite HD Symmetric Tip Catheter 19cm/51377; NEXHDSY1552301/NexSite HD Symmetric Tip Catheter 23cm/51378; NEXHDSY1555501/NexSite HD Symmetric Tip Catheter 55cm/51380; NEXHDSY1552701/NexSite HD Symmetric Tip Catheter 27cm/51435;