FDA-Device2016-04-20Class II
BARDEX I.C. Anti-Infective 2-Way 3cc Foley Catheter, Rx only. 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 3cc Foley Catheter, Rx only. 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-1357-2016Don't want to check this manually?
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