C.R. Bard, Inc.: Medical Device Recall in 2016 - (Recall #: Z-1357-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

BARDEX I.C. Anti-Infective 2-Way 3cc Foley Catheter, Rx only. Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.

Product Classification:

Class II

Date Initiated: December 18, 2015

Date Posted: April 20, 2016

Recall Number: Z-1357-2016

Event ID: 72922

Reason for Recall:

Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.

Status: Terminated

Product Quantity: 1,428,000 units (total)

Code Information:

Catalog numbers: 0165I108 and 065SI10; All lot numbers produced with IFU (PK7634040) are affected.

Distribution Pattern:

Distributed US (nationwide) and the countries of Canada and Australia.

Voluntary or Mandated:

Voluntary: Firm initiated