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FDA (Device enforcement)Recalled 2025-11-06class ii

C.R. Bard Inc: Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614

Hazard

Labeling discrepancy; Ureteral stent actual size may not match the actual product label.

Details from the source

Reason for recall: Labeling discrepancy; Ureteral stent actual size may not match the actual product label. 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 Lot/code info: Lot# NGJU4163/UDI: (01)00801741015403

UPC codes

00801741015403

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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