The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1358-2016·Announced 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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II due to a labeling error regarding inflation volume. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries or illnesses are rated as Moderate (2).

Plain-English summary

C.R. Bard, Inc. is recalling 1,428,000 units of Bardex I.C. Anti-Infective 2-Way 5cc Foley Catheters. The recall is due to a labeling error in the Instructions for Use (IFU) that specifies an incorrect inflation volume for the catheter balloon.

The affected products are intended for urinary bladder drainage in female patients requiring catheterization for the management of incontinence, voiding dysfunction, and surgical procedures. The recall covers catalog numbers 01655SI12 through 01655SI30. All lot numbers produced with the specific IFU (PK7634040) are affected.

The products were distributed nationwide in the United States, as well as in Canada and Australia. The FDA has classified this as a Class II recall, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences.

The recalled product

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.
Manufacturer
C.R. Bard, Inc.
Category
Medical Device — Catheters
Hazard
Affected units
1,428,000

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

  • Code(s): Catalog numbers: 01655SI12
  • 01655SI14
  • 01655SI16
  • 01655SI18
  • 01655SI20
  • 01655SI22
  • 01655SI24
  • 01655SI26

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by C.R. Bard, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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