C.R. Bard, Inc. recalls Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units

Recall date

October 2, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0198-2016

FDA classification

Class III

Brand / firm

C.R. Bard, Inc.

Sold / distributed

Nationwide Distribution including CA, FL, IL, MO, NJ, OR, PA, TX & WA.

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units