Recall Z-1699-2021— MARVAO MEDICAL DEVICES LTD.
Class II · Ongoing
Class II FDA medical device recall by MARVAO MEDICAL DEVICES LTD., initiated 2020-02-11. It names one FDA 510(k) clearance: K173805. Product: NexSite HD, Hemodialysis Symmetric Tip Catheter for long term use. Reason: The action is to ensure consistency between the Directions for Use (DFU) in the field and the DFU on the website..
- Recalling firm
- MARVAO MEDICAL DEVICES LTD.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2020-02-11
- Firm location
- Galway, Ireland
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.