Device product
REF: 382944, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
Z-2003-2025
Product summary
- Event
- Event 96865
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 50 units
- Official record key
device-enforcement:Z-2003-2025
Official wording
Reason: Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Code information: Lot# 4298108/UDI:382903829446
Distribution pattern: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Belgium, Canada, Chile, Colombia, Guatemala, Japan, New Zealand, Panama, Philippines, Singapore, Vietnam.
Derived failure modes
-
Unknown
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.