FDAClass IIJanuary 18, 2017

MiniLoc¿ Safety Infusion Set Winged without Y-Injection recall

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.

Why was MiniLoc¿ Safety Infusion Set Winged without Y-Injection recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Numbers: ASAQS0343 & ASZIS027

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.
Recalling firm
Bard Access Systems
Quantity
7,200 units
Distribution
Worldwide Distribution - US Nationwide in the states of CA, CO, FL, GA, HI, IL, MA, MD, NJ, OH, OR, TX.
Recall date
January 18, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls