Bardex Foley Catheter Recalled for Incorrect Retainer Cap Print
C.R. Bard is recalling specific lots of Bardex Foley catheters because the retainer cap print is incorrect.
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, but the source text identifies the issue as an incorrect print on the retainer cap, which is a labeling/packaging defect rather than a direct contamination or structural failure causing injury.
Plain-English summary
C.R. Bard, Inc. is recalling Bardex Lubricath 3-Way 75cc Continuous Irrigation Foley Catheters (Creevy), 22Fr. (Catalog # 01267522). The recall involves Lot #s NGBR0383 and NGBR2129. The product was distributed in Florida, New York, Minnesota, and Texas, as well as in Canada, Japan, and Taiwan.
The recall was initiated because the retainer cap on the catheter has an incorrect print. 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 facilities and consumers who have these specific lots should stop using the product and contact C.R. Bard for instructions on how to return or dispose of the catheters.
The recalled product
- Product
- Bardex Lubricath 3-Way 75cc Continuous Irrigation Foley Catheter (Creevy), 22Fr. Rx (01267522)
- Manufacturer
- C.R. Bard, Inc.
- Hazard
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)
- Catalog # 01267522 Lot #'s: NGBR0383 and NGBR2129
Distribution
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