B. Braun Recalls Spinal Anesthesia Trays with Lidocaine Component
B. Braun Medical is voluntarily recalling specific lots of Custom Spinal Anesthesia Trays because the lidocaine component does not meet color 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 hazard is a minor labeling/specification error (color) with no reported injuries or illnesses, fitting the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
B. Braun Medical, Inc. is voluntarily recalling specific lots of their Custom Spinal Anesthesia Tray. The recall involves a drug component, 5% Lidocaine Hydrochloride and 7.5% Dextrose Injection, USP, which is used for the injection of anesthetics to provide regional anesthesia.
The recall is being conducted because the drug product does not meet the specification for color throughout its shelf life. The affected drug component was previously recalled by Hospira Inc. for the same reason.
The recall affects 1,704 units distributed in the United States to Alabama, Illinois, Oklahoma, Minnesota, Massachusetts, and Wisconsin. Consumers and healthcare providers should check their inventory for the specific catalog numbers and lot numbers listed in the official recall notice and stop using the affected products.
The recalled product
- Product
- Affected Pain Control Tray Component (5% Lidocaine Hydrochloride and 7.5% DExtrose Injection, USP) Injection of anesthetics to provide regional anesthesia
- Manufacturer
- B. Braun Medical, Inc.
- Hazard
- Affected units
- 1,704
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 (20)
- Catalog Number: 560399 (Lot # 0061418559
- 0061422389
- 0061434523
- 0061438084
- 0061440188
- 0061446168
- 0061450971
- 0061459227
- 0061464239
- Catalog Number: 560511 (Lot # 0061413435
- 0061425996
- 0061438393
- 0061452272
- 0061465310)
- Catalog # 560605 (0061420240
- 0061429962
- 0061442280
- 0061449510
- 0061460497
- 0061471580)
Distribution
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