Bard Access Systems: Bard Access Systems announces a voluntary field action for the SafeStep¿ Huber Needle Set with Y-Injection Site and MiniLoc¿ Safety Infusion Set Winged without Y-Injection Site devices because sets may contain one or more units where the needle length and gage differs from the length and gage described on the label.

Agency Publication Date: January 10, 2017

Affected Products

Product: MiniLoc¿ Safety Infusion Set Winged without Y-Injection Site. Product Code: S02022-75. Packaged as single units in thermoformed trays. There are 20 MiniLoc¿ trays per case and 160 per carton. Product Usage: Intended for the administration of fluids and drugs, or blood sampling through surgically implanted vascular ports.

Lot Numbers: ASAQS0343 & ASZIS027

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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 surgically implanted vascular ports.

Lot Number: ASZKS076

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Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 76008

Status: Resolved

Manufacturer: Bard Access Systems

Manufactured In: United States

Units Affected: 2 products (7,200 units; 8000 units)

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Sources: FDA iRES · Raw API Response

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Affected Products

Lot Numbers: ASAQS0343 & ASZIS027

Lot Numbers:

Numbers

Lot Number: ASZKS076

Lot Numbers:

Number