B. Braun Recalls Pencan Spinal Needle Trays Due to Foreign Matter
B. Braun Medical is recalling 11,920 units of Pencan Spinal Needle Trays because they contain 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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard involves foreign matter that was tested for biocompatibility, fitting the criteria for a moderate severity recall without reported adverse health consequences.
Plain-English summary
B. Braun Medical, Inc. (BBMI) is recalling 11,920 units of Pencan Spinal Needle Trays (Product Catalog Number 333865). These trays are used for local anesthesia of the skin prior to the insertion of regional anesthesia needles. The recall was initiated due to the presence of loose polypropylene foreign matter that exceeded release specifications.
The foreign matter has been identified as a product hub material. According to the source text, this material was tested for biocompatibility per ISO 10993 during the product development process. The affected units were distributed nationwide in the United States.
The recall includes specific lot codes: 0061483775, 0061486469, 0061519983, 0061525310, 0061529050, 0061531352, 0061535252, and 0061540004. Healthcare providers and consumers should check their inventory for these specific catalog numbers and lot codes to identify affected units.
The recalled product
- Product
- Pencan Spinal Needle Tray. Product Catalog Number: 333865. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
- Manufacturer
- B. Braun Medical, Inc.
- Hazard
- Affected units
- 11,920
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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