Antibacterial Hydro Personal Catheter recall: Labeling Error
Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units
Why was Antibacterial Hydro Personal Catheter recalled?
Incorrect unit labeling. The case label and shelf box are correct, Product Code 63512 and Catheter Size 12 French. The unit label (catheter package) may state Product Code 63516 and Catheter Size 16 French.
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?
Lot 53620131
- Product
- Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units
- Recalling firm
- C.R. Bard, Inc.
- Quantity
- 4,170 each
- Distribution
- Nationwide Distribution including CA, FL, IL, MO, NJ, OR, PA, TX & WA.
- Recall date
- November 11, 2015
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)