Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0986-2017·Announced 2017-01-18

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.

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: 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…
Manufacturer: Bard Access Systems
Category: Medical Device — Needle Sets
Hazard: mis-labeling
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

Distributed nationwide across the United States.

The notice also names 12 states specifically:

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.

See all 2 products in this recall →

Same manufacturer · Bard Access Systems

See all →

Moderate
Bard Access Systems Recalls MiniLoc Safety Infusion Sets Due to Labeling Errors
FDA (Devices) · 2017-01-18
Moderate
Bard Access Systems Recalls StatLock PICC Plus Devices Due to Missing Identifiers
FDA (Devices) · 2017-01-18
Moderate
Bard Access Systems Recalls StatLock Catheter Stabilization Devices
FDA (Devices) · 2017-01-18
Moderate
Bard Access Systems Recalls PowerPICC Catheter Marketing Brochures
FDA (Devices) · 2015-09-30
Low
Bard Access Systems Recalls PowerPICC Solo Catheter Kits for Labeling Errors
FDA (Devices) · 2015-07-15

Same hazard · mis labeling