BD Max StaphSR Reagent Kit Recall Due to Improperly Sealed Foil Bags
Becton Dickinson is recalling BD Max StaphSR 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, which typically indicates a situation where use of the product could cause temporary or medically reversible health consequences. The source text describes a packaging defect (improperly sealed foil bags) without reporting any specific injuries, illnesses, or fatalities, aligning with a moderate severity assessment for a precautionary recall of a medical device component.
Plain-English summary
Becton Dickinson & Co. is recalling 207 units of the BD Max StaphSR Kit (Catalog # 443419). The recall involves specific lots identified by lot numbers 9086668 and 9092724, both with an expiration date of September 2, 2020.
The recall was initiated because the foil bags containing extraction tubes for BD MAX Reagent products may not have been sealed properly. This defect could potentially affect the integrity of the reagents.
The affected products were distributed to various locations in the United States, including Alabama, Arizona, California, Florida, New York, and Texas, as well as internationally in countries such as Australia, Canada, China, and Japan. Users of these kits should check their inventory for the specific lot numbers and expiration dates listed above and contact the manufacturer for further instructions.
The recalled product
- Product
- Kit BD Max StaphSR; Catalog # 443419
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 207
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 (6)
- Lot # 9086668
- UDI (GTIN
- DI+PI) : (01)00382904434199 (17)200902(10)9086668(30)1
- Exp :9/2/2020 Lot # 9092724
- DI+PI) :(01)00382904434199 (17)200902(10)9092724(30)1
- Exp: 9/2/2020
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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