The Recall Desk
ModerateFDA (Devices)·Z-2336-2019·Announced 2019-08-28

Becton Dickinson Recalls BD Max Vaginal Panel Kits Due to Seal Defects

Becton Dickinson is recalling 666 BD Max Vaginal Panel 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 any specific injuries, illnesses, or fatalities. This aligns with the rubric for moderate severity involving potential risks or minor defects.

Plain-English summary

Becton Dickinson & Co. is recalling 666 units of the BD Max Vaginal Panel (Catalog # 443712). The recall involves specific lots (9092737, 9092738, and 9127920) with an expiration date of March 21, 2020.

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 defect could potentially compromise 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. Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the affected kits.

The recalled product

Product
Kit BD Max Vaginal Panel; Catalog # 443712
Manufacturer
Becton Dickinson & Co.
Category
Medical Device — In Vitro Diagnostics
Hazard
Affected units
666

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 (8)

  • Lot # 9092737
  • UDI (GTIN
  • DI+PI): (01)00382904437121 (17)200321(10)9092737(30)1
  • Exp : 3/21/2020 Lot # 9092738
  • DI+PI): (01)00382904437121 (17)200321(10)9092738(30)1
  • Exp :3/21/2020 Lot # 9127920
  • DI+PI): (01)00382904437121 (17)200321(10)9127920(30)1
  • Exp : 3/21/2020

Distribution

Distributed in 38 states:

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 →

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