The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1359-2016·Announced 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.

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 are rated as Moderate.

Plain-English summary

C.R. Bard, Inc. is recalling the Bardex I.C. Anti-Infective 2-Way Red Latex Foley Catheter, 5cc (Council Model). The recall involves 1,428,000 units distributed nationwide in the United States, as well as in Canada and Australia. The affected products are identified by Catalog numbers 0146SI16, 0146SI18, 0146SI20, and 0146SI22, and include all lot numbers produced with the specific Instructions for Use (IFU) document PK7634040.

The recall was initiated due to a labeling error in the Instructions for Use. The IFU contains an incorrect inflation volume for the catheter balloon. This is a Class II recall, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences.

Healthcare providers and facilities should stop using the affected catheters and contact C.R. Bard for instructions on how to return the products. Patients who have had these catheters inserted should consult their healthcare provider if they have concerns regarding the balloon inflation volume.

The recalled product

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.
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 (2)

  • CodeCatalog numbers: 0146SI16
  • 0146SI18

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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