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Recall Observatory FDA recall evidence

Device 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.

Z-0986-2017

December 19, 2016

Class II

Product summary

Firm
Bard Access Systems
Event
Event 76008
Status
Terminated
Classification
Class II
Quantity
8000 units
Official record key
device-enforcement:Z-0986-2017

Official wording

Reason: 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.

Code information: Lot Number: ASZKS076

Distribution pattern: Worldwide Distribution - US Nationwide in the states of CA, CO, FL, GA, HI, IL, MA, MD, NJ, OH, OR, TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.