Device product
Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614
Z-0905-2026
Product summary
- Firm
- C.R. Bard Inc
- Event
- Event 97985
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 116 units
- Official record key
device-enforcement:Z-0905-2026
Official wording
Reason: Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Code information: Lot# NGJU4163/UDI: (01)00801741015403
Distribution pattern: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IA, IN, KY, LA, MA, MD, MI, MO, ND, NJ, NY, OH, PA, SD, VA, WA, WI and the countries of Canada, EMEA (Belgium, Denmark, Slovakia, Spain, Turkey, United Kingdom, MENA (Jordan), S Africa), Greater Asia (China).
Derived failure modes
-
Unknown
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.