C.R. Bard, Inc. recalls BARDEX I.C. Anti-Infective 2-Way Red Latex Foley Catheter, 5cc (Council Model); Intended for urinary bladder drainage i…
- Recall date
- December 18, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1359-2016
- FDA classification
- Class II
- Brand / firm
- C.R. Bard, Inc.
- Sold / distributed
- Distributed US (nationwide) and the countries of Canada and Australia.
Why it was recalled
Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
BARDEX I.C. Anti-Infective 2-Way Red Latex Foley Catheter, 5cc (Council Model); Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.
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