FDA-Device2016-04-20Class II
BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter. Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.
C.R. Bard, Inc.
Hazard
Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.
Sold states
Distributed US (nationwide) and the countries of Canada and Australia.
Affected count
1,428,000 units (total)
Manufactured in
8195 Industrial Blvd NE, N/A, Covington, GA, United States
Products
BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter. Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1358-2016Don't want to check this manually?
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