Bard PerFix Light Plug Recalled for Labeling Mismatch
Davol, Inc. is recalling 78 units of Bard PerFix Light Plug because the patient record label did not match the actual product in the 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, but the specific hazard is a labeling mismatch without reported injuries or illnesses, fitting the criteria for a moderate severity labeling error.
Plain-English summary
Davol, Inc., a subsidiary of C. R. Bard, Inc., is recalling 78 units of the Bard PerFix Light Plug. The product is a medical device indicated for the reinforcement of soft tissue in procedures involving soft tissue repair, such as groin hernia defects.
The recall was initiated because the patient record peel-off label product code and size did not match the other labeling and the actual product in the packaging. This labeling discrepancy could lead to incorrect documentation of the implanted device.
The affected units are from Lot # HUYD0176. The products were distributed in the United States, including the states of California, New Mexico, Ohio, Delaware, Minnesota, Utah, Maryland, and Missouri. Healthcare providers should verify the labeling of any implanted devices against the patient records to ensure accuracy.
The recalled product
- Product
- Bard¿ PerFix Light Plug The Bard¿ PerFix Light Plug is indicated for reinforcement if soft tissue, where weakness exists, in procedures involving soft tissue repair, such as groin hernia defects.
- Manufacturer
- Davol, Inc., Subs. C. R. Bard, Inc.
- Category
- Medical Device — Surgical Mesh
- Hazard
- Affected units
- 78
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# HUYD0176
Distribution
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