C.R. Bard Recalls Antibacterial Hydro Personal Catheters Due to Labeling Error
C.R. Bard is recalling 4,170 units of Antibacterial Hydro Personal Catheters because the unit label may incorrectly state the product code and size.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a documentation/labeling error rather than a physical defect or contamination.
Plain-English summary
C.R. Bard, Inc. is recalling 4,170 units of Antibacterial Hydro Personal Catheters, Male 12 Fr, Product Code 63512. The recall is due to incorrect unit labeling. While the case label and shelf box correctly identify the product as Product Code 63512 and Catheter Size 12 French, the individual unit label (catheter package) may incorrectly state Product Code 63516 and Catheter Size 16 French.
The affected product is sold in boxes of 30 units. The recall covers Lot 53620131. The product was distributed nationwide, including in California, Florida, Illinois, Missouri, New Jersey, Oregon, Pennsylvania, Texas, and Washington.
Consumers and healthcare facilities should stop using the affected catheters and contact C.R. Bard for further instructions or a replacement.
The recalled product
- Product
- Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units
- Manufacturer
- C.R. Bard, Inc.
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 4,170
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 (1)
- Lot 53620131
Distribution
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