Device product
NexSite HD, Hemodialysis Symmetric Tip Catheter for long term use
Z-1699-2021
Product summary
- Event
- Event 87827
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 292 devices
- Official record key
device-enforcement:Z-1699-2021
Official wording
Reason: The action is to ensure consistency between the Directions for Use (DFU) in the field and the DFU on the website.
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;
Distribution pattern: U.S.: CO, NC, SC, TX, O.U.S.: Not provided
Derived failure modes
-
Unknown
The action is to ensure consistency between the Directions for Use (DFU) in the field and the DFU on the website.