The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1357-2016·Announced 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.

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 and involves a labeling error regarding inflation volume. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries fall under the Moderate severity level.

Plain-English summary

C.R. Bard, Inc. is recalling 1,428,000 units of Bardex I.C. Anti-Infective 2-Way 3cc 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 catalog numbers 0165I108 and 065SI10. All lot numbers produced with the specific IFU (PK7634040) are included in the recall. The devices were distributed nationwide in the United States, as well as in Canada and Australia.

These catheters are intended for urinary bladder drainage in female patients requiring catheterization for the management of incontinence, voiding dysfunction, and surgical procedures. Healthcare providers and patients should verify the correct inflation volume for these specific catalog numbers and IFU versions before use.

The recalled product

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.
Manufacturer
C.R. Bard, Inc.
Category
Medical Device — Urological Catheter
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 (2)

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

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 →

Related recalls

Same manufacturer · C.R. Bard, Inc.

See all →

Same hazard · mis labeling

See all →

Similar recalls