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.
Reported: April 20, 2016 Initiated: December 18, 2015 #Z-1358-2016
Product Description
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.
Reason for Recall
Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.
Details
- Recalling Firm
- C.R. Bard, Inc.
- Units Affected
- 1,428,000 units (total)
- Distribution
- Distributed US (nationwide) and the countries of Canada and Australia.
- Location
- Covington, GA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by C.R. Bard, Inc.. Units affected: 1,428,000 units (total).
Why was this product recalled? ▼
Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 20, 2016. Severity: Moderate. Recall number: Z-1358-2016.
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