C.R. Bard, Inc.: Medical Device Recall in 2016 - (Recall #: Z-1358-2016)

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 5cc Foley Catheter. 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-1358-2016

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:

Code(s): Catalog numbers: 01655SI12, 01655SI14, 01655SI16, 01655SI18, 01655SI20, 01655SI22, 01655SI24, 01655SI26, 01655SI28 and 01655SI30. 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