C.R. Bard, Inc.: Medical Device Recall in 2015 - (Recall #: Z-0198-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: October 2, 2015

Date Posted: November 11, 2015

Recall Number: Z-0198-2016

Event ID: 72398

Reason for Recall:

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.

Status: Terminated

Product Quantity: 4,170 each

Code Information:

Lot 53620131

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated