NexSite HD hemodialysis catheter directions for use consistency recall
MARVAO MEDICAL DEVICES is correcting the Directions for Use (DFU) for NexSite HD hemodialysis catheters to ensure consistency between field documentation and website information for 292 devices distributed in the U.S.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall addressing documentation inconsistency with no reported illnesses, injuries, or device defects. Precautionary recalls correcting labeling or documentation issues without reported harm are classified as Moderate per the rubric.
Plain-English summary
The FDA has announced a recall of 292 NexSite HD Hemodialysis Symmetric Tip Catheters manufactured by MARVAO MEDICAL DEVICES LTD. The devices were distributed in Colorado, North Carolina, South Carolina, and Texas.
The recall addresses inconsistencies between the Directions for Use (DFU) provided with devices currently in the field and the DFU published on the manufacturer's website. The FDA is ensuring that all information regarding proper use of the device is consistent across all sources.
Healthcare providers and facilities using these devices should review the Directions for Use materials they have on hand. For updated guidance or questions regarding this recall, contact the manufacturer or the FDA.
The recalled product
- Product
- NexSite HD, Hemodialysis Symmetric Tip Catheter for long term use
- Manufacturer
- MARVAO MEDICAL DEVICES LTD.
- Affected units
- 292
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- 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
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