FDA Enforcement
Class II
Ongoing
Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614
Recall: Z-0905-2026
·
Reported December 17, 2025
Enforcement
- Recall Number
- Z-0905-2026
- Event ID
- 97985
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- C.R. Bard Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 17, 2025
- Initiation Date
- November 6, 2025
- Classification Date
- December 11, 2025
- Address
- 8195 Industrial Blvd Ne, N/A, Covington, GA, 30014-1497, United States
Description
Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614
Reason
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Code Info
Lot# NGJU4163/UDI: (01)00801741015403
Distribution
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).
Quantity
116 units