Bard Access Systems Recalls SafeStep Huber Needle Sets Due to Labeling Errors
Bard Access Systems is recalling SafeStep Huber Needle Sets because some units may have needle lengths or gauges that differ from the label.
What this means for you
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: The recall is classified as FDA Class II and involves a labeling error where the physical product does not match the label description. No injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Bard Access Systems has announced a voluntary field action for SafeStep Huber Needle Sets with Y-Injection Site and MiniLoc Safety Infusion Sets Winged without Y-Injection Site. The recall is being issued because some sets may contain units where the needle length and gauge differ from the specifications described on the label.
The affected product is the SafeStep Huber Needle Set with Y-Injection Site, Product Code LH-0029YN. These devices are intended for the administration of fluids and drugs, or blood sampling through surgically implanted vascular ports. The recall involves 8,000 units from Lot Number ASZKS076.
The products were distributed worldwide and nationwide in the United States, specifically in the states of California, Colorado, Florida, Georgia, Hawaii, Illinois, Massachusetts, Maryland, New Jersey, Ohio, Oregon, and Texas. Users should verify the needle length and gauge of their devices against the label and contact Bard Access Systems for further instructions.
The recalled product
- Product
- SafeStep¿ Huber Needle Set with Y-Injection Site. Product Code: LH-0029YN. Packaged as single units in thermoformed trays. There are 25 SafeStep¿ trays per case and 100 per carton. Product Usage: Intended for the administration of fluids and drugs, or blood sampling through s
- Manufacturer
- Bard Access Systems
- Category
- Medical Device — Needle Sets
- Hazard
- Affected units
- 8,000
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 (1)
- Lot Number: ASZKS076
Distribution
Part of a larger recall action
This product is one of 2 recalled by Bard Access Systems under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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