Z-1699-2021 Class II Ongoing
FDA device recall Z-1699-2021 was initiated by MARVAO MEDICAL DEVICES LTD. on February 11, 2020 and is designated Class II. Reason for recall: The action is to ensure consistency between the Directions for Use (DFU) in the field and the DFU on the website. The recall status is ongoing. Affected quantity: 292 devices.
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;