The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2386-2015·Announced 2015-08-26

C.R. Bard Recalls Magic3 Female Intermittent Urinary Catheters

C.R. Bard is recalling 37,686 Magic3 Hydrophilic-coated 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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a potential breach of sterile packaging, which is a significant quality issue but does not explicitly report injuries or deaths in the provided text, fitting the Moderate category for precautionary recalls of medical devices.

Plain-English summary

C.R. Bard, Inc. is recalling 37,686 units of Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 14 Fr, (30/box), Product Code 51614. The recall is being conducted due to a potential breach of the sterile barrier packaging.

The affected products were 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 recall includes specific lot numbers ranging from 73600003 to 73600218.

Consumers and healthcare providers should check their inventory for the specific product code and lot numbers listed in the recall notice. If the sterile barrier packaging is compromised, the catheters should not be used. Users should contact C.R. Bard, Inc. for further instructions or to arrange for the return of the affected products.

The recalled product

Product
Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 14 Fr, (30/box), Product Code 51614. Intermittent catheter.
Manufacturer
C.R. Bard, Inc.
Category
Medical Device — Catheters
Hazard
Affected units
37,686

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 (20)

  • Lot Number 73600003
  • 73600006
  • 7360007
  • 73600011
  • 73600012
  • 73600013
  • 73600016
  • 73600017
  • 73600020
  • 73600021
  • 73600024
  • 73600080
  • 73600081
  • 73600082
  • 73600095
  • 73600096
  • 73600097
  • 73600123
  • 73600124
  • 73600125

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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