The Recall Desk
HighFDA (Devices)·Z-0568-2018·Announced 2018-02-21

B. Braun Recalls Perifix Anesthesia Trays Due to Foreign Matter

B. Braun Medical is recalling 700 Perifix Single Dose Epidural Anesthesia Trays because they contain loose polypropylene foreign matter above release specifications.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a foreign matter defect that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

B. Braun Medical, Inc. (BBMI) is recalling 700 units of the Perifix Single Dose Epidural Anesthesia Tray (Product Catalog Number: 332252). The recall is due to the presence of loose polypropylene foreign matter that exceeds release specifications. The affected units were distributed nationwide in the United States.

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 recall involves various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle.

Healthcare providers and consumers should stop using the affected trays immediately. The specific lot codes associated with this recall are 0061523813 and 0061536453. Users should contact B. Braun Medical, Inc. for further instructions or to arrange for the return of the product.

The recalled product

Product
Perifix Single Dose Epidural Anesthesia Tray. Product Catalog Number: 332252. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
Affected units
700

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)

  • 0061523813. 0061536453.

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 →