Bard Magic 3 Antibacterial Catheters Recalled for Missing Coating
C.R. Bard is recalling specific lots of Bard Magic 3 Antibacterial Hydrophilic Intermittent Catheters because they may lack the hydrophilic coating.
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 does not report any illnesses, injuries, or hospitalizations, indicating a theoretical risk of harm rather than a confirmed adverse event.
Plain-English summary
C.R. Bard, Inc. is recalling specific lots of Bard Magic 3 Antibacterial Hydrophilic Intermittent Catheter Female, 14 FR (30/box). The recall involves 45,270 units of the device, which is intended for urinary bladder drainage in patients requiring catheterization for the management of incontinence, voiding dysfunction, and surgical procedures.
The recall was initiated because specific lots labeled as an Antibacterial Hydrophilic Intermittent Catheter may lack the hydrophilic coating. The affected products are identified by Catalog No. 51514 and Lot Nos. 53623024, 53623054, 53623047, and 53623122, with an expiration date of 01/31/2020.
The affected units were distributed to Alabama, Arizona, California, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, and Washington. Patients and healthcare providers should check their inventory for these specific lot numbers and contact C.R. Bard for further instructions.
The recalled product
- Product
- Bard Magic 3 Antibacterial Hydrophilic Intermittent Catheter Female, 14 FR (30/box), Rx Only intended for urinary bladder drainage in patients requiring catheterization for management of incontinence, voiding dysfunction, and surgical procedures.
- Manufacturer
- C.R. Bard, Inc.
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 45,270
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 (6)
- Catalog No. 51514
- Lot No. 53623024
- 53623054
- 53623047
- 53623122
- Exp Date 01/31/2020
Distribution
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