BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter. recall: Labeling Error
BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter. Intended for urinary bladder drainage in female patients requiring catheterization for management…
Why was BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter. recalled?
Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Code(s): Catalog numbers: 01655SI12, 01655SI14, 01655SI16, 01655SI18, 01655SI20, 01655SI22, 01655SI24, 01655SI26, 01655SI28 and 01655SI30. All lot numbers produced with IFU (PK7634040) are affected.
- Product
- BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter. Intended for urinary bladder drainage in female patients requiring catheterization for management…
- Recalling firm
- C.R. Bard, Inc.
- Quantity
- 1,428,000 units (total)
- Distribution
- Distributed US (nationwide) and the countries of Canada and Australia.
- Recall date
- April 20, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)