B. Braun Recalls Perifix Epidural Anesthesia Trays Due to Discoloration
B. Braun Medical is recalling 433 Perifix Continuous Epidural Anesthesia Pain Control Trays because the DuraPrep solution may be discolored from unintended sterilant exposure.
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 describes a potential cosmetic defect (discoloration) without reporting any adverse health consequences, injuries, or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
B. Braun Medical, Inc. is recalling 433 units of Perifix Continuous Epidural Anesthesia Pain Control Trays. These trays are used for the injection of anesthetics to provide regional anesthesia for pain management. The recall was initiated because the DuraPrep solution contained in the trays may have been exposed to a sterilant during the sterilization process performed by the supplier, resulting in potential discoloration.
The affected products were distributed nationally. The recall includes specific product catalog numbers and lot numbers, which are listed in the official FDA recall record Z-0150-2016. The agency has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare providers and facilities that have received these specific trays should stop using them and contact B. Braun Medical, Inc. for instructions on how to return or dispose of the affected units. Consumers should not use these medical devices at home, as they are intended for professional medical use.
The recalled product
- Product
- Perifix Continous Epidural Anesthesia Pain Control Trays; Injection of anesthetics to provide regional anesthesia for pain management.
- Manufacturer
- B. Braun Medical, Inc.
- Affected units
- 433
Distribution
Distribution scope not specified by the agency.
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