C.R. Bard Inc: BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- C.R. Bard Inc
- Product
- BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630
- Reason / hazard
- Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- 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).
- Recall initiated
- 2025-11-06
- Code info
- Lot# NGJU4327/UDI:(01)00801741015786
- Product quantity
- 116 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Covington
- State
- GA
- Country
- United States
- Event id
- 97985
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