B. Braun Recalls PENCAN Spinal Anesthesia Trays Due to Foreign Matter
B. Braun Medical is recalling PENCAN Spinal Anesthesia Trays because they contain needles with loose polypropylene foreign matter above release specifications.
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. The hazard involves foreign matter that has been tested for biocompatibility, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
B. Braun Medical, Inc. (BBMI) is recalling 700 units of PENCAN Spinal Anesthesia Trays, Product Catalog Number 560590. These trays are used for local anesthesia of the skin prior to the insertion of regional anesthesia needles. The recall is due to the presence of loose polypropylene foreign matter in the 22GA 1-1/2in SafetyGlide Needle contained within the kits.
The foreign matter was identified as product hub material. This material was tested for biocompatibility per ISO 10993 during the product development process. The recall is being initiated because the amount of foreign matter present was above release specification.
The affected products were distributed nationwide in the United States. The specific product codes associated with this recall are 0061525340 and 0061535836. Healthcare providers and facilities should check their inventory for these specific catalog numbers and codes to identify affected units.
The recalled product
- Product
- PENCAN Spinal Anesthesia Tray. Product Catalog Number: 560590. 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
- 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)
- 0061525340. 0061535836.
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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