BD Max ExK TNA 2 Extraction Tube Kit Recall for Sealing Defects
Becton Dickinson is recalling BD Max ExK TNA 2 kits because foil bags containing extraction tubes may not have been sealed properly.
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 the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity rating.
Plain-English summary
Becton Dickinson & Co. is recalling 86 units of the Kit BD Max ExK TNA 2 (Catalog # 442825). The recall is due to a defect where the foil bags containing the extraction tubes may not have been sealed properly.
The affected product is identified by Lot # 9106876 and has an expiration date of 11/7/2020. The agency classifies this as a Class II recall. The product was distributed to various U.S. states and international locations, including Australia, Belgium, Brazil, Canada, Chile, China, Hong Kong, Japan, Korea, Mexico, Singapore, and Taiwan.
Consumers and healthcare providers should stop using the affected kits and contact Becton Dickinson for further instructions.
The recalled product
- Product
- Kit BD Max ExK TNA 2; Catalog # 442825
- Manufacturer
- Becton Dickinson & Co.
- Hazard
- Affected units
- 86
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 (4)
- Lot # 9106876
- UDI (GTIN
- DI+PI): (01)00382904428259 (17)201107(10)9106876(30)1
- Exp: 11/7/2020
Distribution
Part of a larger recall action
This product is one of 19 recalled by Becton Dickinson & Co. 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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