The Recall Desk

FDA (Devices) recall action 72922

C.R. Bard, Inc. recalled 3 products on 2016-04-20

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2016-04-20
Critical
0
Units
4,284,000

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–3 of 3

  • ModerateFDA (Devices)··2016-04-20

    C.R. Bard Recalls Foley Catheters Due to Labeling Error

    C.R. Bard is recalling 1.4 million latex Foley catheters because the instructions for use list an incorrect inflation volume.

    Product
    BARDEX I.C. Anti-Infective 2-Way Red Latex Foley Catheter, 5cc (Council Model); Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-04-20

    Bard Foley Catheter Recalled for Incorrect Inflation Volume Labeling

    C.R. Bard is recalling 1.4 million Bardex Foley catheters because the instructions for use list an incorrect inflation volume.

    Product
    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.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-04-20

    Bard Foley Catheter Recall Due to Incorrect Inflation Volume Labeling

    C.R. Bard is recalling 1.4 million Bardex Foley catheters because the instructions for use list an incorrect inflation volume.

    Product
    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.
    Category
    Distribution
    0 states