United StatesBard InLay Optima ureteral stent kits — REF 787614 (6 Fr x 14 cm), REF 788426 (4.7 Fr x 26 cm), REF 788630 (6 Fr x 30 cm), and REF 78826 (8 Fr x 26 cm) — lots NGJU4163, NGJU4181, NGJU4327, NGJU4328 (UDIs (01)00801741015403, (01)00801741015687, (01)00801741015786, (01)00801741015922) are affected. They were recalled due to a labeling discrepancy where the ureteral stent actual size may not match the product label.
What's being recalled
Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614
BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 788426
BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630
BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 78826
Recalling firm: C.R. Bard Inc, Covington, GA, United States.
How to identify it
Lot# NGJU4163/UDI: (01)00801741015403 Lot# NGJU4181/UDI: (01)00801741015687 Lot# NGJU4327/UDI:(01)00801741015786 Lot# NGJU4328/UDI: (01)00801741015922
The hazard
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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).
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)