The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2388-2015·Announced 2015-08-26

C.R. Bard Recalls Magic3 Female Intermittent Urinary Catheters for Sterile Breach

C.R. Bard is recalling 534,972 Magic3 Female Intermittent Urinary Catheters due to a potential breach of the sterile barrier packaging.

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 the source text describes a potential breach of sterile packaging without reporting specific injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

C.R. Bard, Inc. is recalling 534,972 units of the Magic3 Hydrophilic-coated Female Intermittent Urinary Catheter 14 Fr in the Insertion Supply Kit, Product Code 51614S. The recall is being conducted due to a potential breach of the sterile barrier packaging.

The affected products are distributed nationwide, including in Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, and the District of Columbia. The specific lot numbers involved are 53620387, 53621274, and 53621279.

Consumers and healthcare providers should stop using the affected catheters and contact C.R. Bard, Inc. for further instructions or a replacement.

The recalled product

Product
Magic3 Hydrophilic-coated Female Intermittent Urinary Catheter 14 Fr in the Insertion Supply Kit, Product Code 51614S. Intermittent catheter.
Manufacturer
C.R. Bard, Inc.
Category
Medical Device — Catheters
Hazard
Affected units
534,972

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 (3)

  • Lot Number 53620387
  • 53621274
  • 53621279

Distribution

Distributed nationwide across the United States.

The notice also names 43 states specifically:

Part of a larger recall action

This product is one of 5 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 5 products in this recall →

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