B. Braun Recalls Spinal Anesthesia Kits Due to Foreign Matter
B. Braun Medical is recalling Spinal & 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, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
B. Braun Medical, Inc. (BBMI) is recalling Spinal & Epidural Anesthesia Trays (Product Catalog Number 555172) that contain 22GA 1-1/2in SafetyGlide Needles. The recall was initiated because the needles were found to have loose polypropylene foreign matter present at levels above the release specification.
The foreign matter has been identified as a product hub material. This material was tested for biocompatibility according to ISO 10993 standards during the product development process. The recall involves 2,660 units that 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
- Spinal & Epidural Anesthesia Tray. Product Catalog Number: 555172. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
- Manufacturer
- B. Braun Medical, Inc.
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 2,660
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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