Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0567-2018·Announced 2018-02-21

B. Braun Recalls Perifix Anesthesia Kits Due to Foreign Matter

B. Braun Medical is recalling Perifix Continuous Epidural Anesthesia Trays because they contain needles with loose polypropylene foreign matter.

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, and the hazard involves foreign matter that has been tested for biocompatibility, indicating a lower risk of serious injury compared to untested contaminants.

Plain-English summary

B. Braun Medical, Inc. (BBMI) is recalling 8,630 units of Perifix Continuous Epidural Anesthesia Trays (Catalog Numbers 332075 and 332266). These kits are used for local anesthesia of the skin prior to the insertion of regional anesthesia needles. The recall was initiated because the kits contain 22GA 1-1/2in SafetyGlide Needles with loose polypropylene foreign matter that exceeded release specifications.

The foreign matter has been identified as product hub material. This material was tested for biocompatibility according to ISO 10993 standards during the product development process. The affected products were distributed nationwide in the United States.

Healthcare providers and consumers should stop using these specific trays and contact B. Braun Medical, Inc. for further instructions or a replacement. The recall is classified as Class II by the FDA.

The recalled product

Product: Perifix Continuous Epidural Anesthesia Tray. Product Catalog Numbers: 332075, 332266. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
Manufacturer: B. Braun Medical, Inc.
Category: Medical Device — Anesthesia Kits
Hazard: foreign-matter
Affected units: 8,630

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.

See all 10 products in this recall →

Same manufacturer · B. Braun Medical, Inc.

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