The Recall Desk
ModerateFDA (Devices)·Z-2332-2019·Announced 2019-08-28

BD Max StaphSR Extraction Tube Sealing Defect Recall

Becton Dickinson is recalling BD Max StaphSR kits because foil bags containing extraction tubes may not be sealed properly.

What this means for you

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 describes a potential sealing defect without reporting specific injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Becton Dickinson & Co. is recalling 283 units of the BD Max StaphSR Kit (Catalog # 443418). The recall involves specific lots (9086668 and 9092724) with an expiration date of 9/2/2020. The product was distributed across numerous US states and internationally to countries including Australia, Belgium, Brazil, Canada, Chile, China, Hong Kong, Japan, Korea, Mexico, Singapore, and Taiwan.

The recall was initiated because the foil bags containing the extraction tubes for the BD MAX Reagent products may not have been sealed properly. This is an FDA Class II recall.

Consumers and healthcare facilities should stop using the affected kits and contact Becton Dickinson for further instructions or a replacement.

The recalled product

Product
Kit BD Max StaphSR; Catalog # 443418
Affected units
283

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.

See all 19 products in this recall →