B. Braun Recalls Perifix Epidural Anesthesia Trays Due to Foreign Matter
B. Braun Medical is recalling Perifix Epidural Anesthesia Trays because they contain needles with loose polypropylene foreign matter above release specifications.
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 does not report any illnesses, injuries, or hospitalizations. The hazard involves foreign matter that has been tested for biocompatibility, fitting the criteria for a moderate risk without reported adverse health consequences.
Plain-English summary
B. Braun Medical, Inc. (BBMI) is recalling various BBMI convenience kits, specifically the Perifix Epidural AnesthesiaTray (Product Catalog Numbers: 551879, 551994, 552024), due to the presence of loose polypropylene foreign matter in the 22GA 1-1/2in SafetyGlide Needle. The foreign matter was identified as product hub material and was found to be above release specification.
The affected product is used for local anesthesia of the skin prior to the insertion of the regional anesthesia needle. A total of 2,480 units were distributed nationwide in the United States. The foreign matter has been tested for biocompatibility per ISO 10993 during the product development process.
Healthcare facilities and consumers should stop using the affected kits and contact B. Braun Medical, Inc. for further instructions or a replacement.
The recalled product
- Product
- Perifix Epidural AnesthesiaTray. Product Catalog Numbers: 551879, 551994, 552024. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
- Manufacturer
- B. Braun Medical, Inc.
- Category
- Medical Device — Anesthesia Kits
- Hazard
- Affected units
- 2,480
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by B. Braun Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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