The Recall Desk
ModerateFDA (Devices)·Z-0571-2018·Announced 2018-02-21

B. Braun Recalls Perifix FX Epidural Anesthesia Trays Due to Foreign Matter

B. Braun Medical is recalling Perifix FX Epidural Anesthesia Trays because they contain needles with loose polypropylene foreign matter above release specifications.

What this means for you

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. The hazard involves foreign matter that was tested for biocompatibility, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity recall.

Plain-English summary

B. Braun Medical, Inc. (BBMI) is recalling 6,720 units of Perifix FX Epidural Anesthesia Trays. The affected product catalog numbers are 551993, 552051, 552083, 552119, and 555569. These trays are used for local anesthesia of the skin prior to the insertion of a regional anesthesia needle.

The recall was initiated because the 22GA 1-1/2in SafetyGlide Needles included in these convenience kits contain loose polypropylene foreign matter that exceeds release specifications. The foreign matter has been identified as product hub material, which was tested for biocompatibility per ISO 10993 during the product development process.

The affected products were distributed nationwide in the United States. The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with the use of these products.

The recalled product

Product
Perifix FX Epidural Anesthesia Tray. Product Catalog Numbers: 551993, 552051, 552083, 552119, 555569. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
Affected units
6,720

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 →