Reported Nov 11, 2015 · Terminated
Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units
C.R. Bard, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: C.R. Bard, Inc. · 8195 Industrial Blvd NE · Covington, GA · 30014-1497
Is this the product you have?
Antibacterial Hydro Personal CatheterMale 12 FrProduct Code 63512sold in boxes of 30 units
- Lot codes and dates
- Lot 53620131
- Amount recalled
- 4,170 each
Where it was sold
Why it was 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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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