The Recall Desk
ModerateFDA (Devices)·Z-0576-2018·Announced 2018-02-21

B. Braun Recalls Contiplex Nerve Block Trays Due to Foreign Matter

B. Braun Medical is recalling 300 Contiplex Nerve Block 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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard involves foreign matter that has been tested for biocompatibility, fitting the criteria for a moderate severity recall without reported adverse events.

Plain-English summary

B. Braun Medical, Inc. (BBMI) is recalling 300 units of the Contiplex Nerve Block Tray, Product Catalog Number 570205. These trays are used for local anesthesia of the skin prior to the insertion of regional anesthesia needles. The recall was initiated because the trays 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 facilities should check their inventory for the specific product catalog number and lot codes 0061539146 and 0061540984. Users should stop using the affected trays and contact B. Braun Medical, Inc. for instructions on how to return or dispose of the products.

The recalled product

Product
Contiplex Nerve Block Tray. Product Catalog Number: 570205. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
Affected units
300

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)

  • 0061539146. 0061540984.

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 →