BD Recalls Spinal Anesthesia Trays Due to Incorrect Labeling
Becton Dickinson is recalling 4,500 BD Spinal Anesthesia Trays because a small number were incorrectly labeled as Epidural Trays.
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 and involves a minor labeling error (mislabeling) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Becton Dickinson & Company is conducting a voluntary recall of 4,500 units of the BD Spinal Anesthesia Tray, Catalog (Ref) 405671, Lot B01K089D. The recall is being issued because a very low number of these trays were incorrectly labeled as BD Single Shot Epidural Trays, Catalog (Ref) 406069.
The affected trays were distributed nationwide. The BD Spinal Anesthesia Tray is intended for use by professional anesthesiologists to perform spinal anesthesia procedures. The mislabeling creates a risk that the wrong tray might be used for the intended procedure.
Healthcare professionals should stop using the affected trays and contact Becton Dickinson for further instructions. Consumers are not expected to have these professional medical devices in their homes.
The recalled product
- Product
- BD Spinal Anesthesia Tray The BD Spinal Anesthesia Tray is intended for use by professional anesthesiologists to perform the spinal anesthesia procedure
- Manufacturer
- Becton Dickinson & Company
- Hazard
- Affected units
- 4,500
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)
- B01K089D
Distribution
Distributed nationwide across the United States.
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