Device 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.
Z-0985-2017
Product summary
- Event
- Event 76008
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,200 units
- Official record key
device-enforcement:Z-0985-2017
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 Numbers: ASAQS0343 & ASZIS027
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
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.