Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2078-2020·Announced 2020-05-27

Becton Dickinson Recalls Bard MyPICC Kits Due to Gown Issue

Becton Dickinson is recalling Bard MyPICC Kits because the included surgical gowns were subject to a supplier recall.

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 precautionary measure due to a supplier recall of a component (surgical gowns) without reported injuries or illnesses in the source text.

Plain-English summary

Becton Dickinson & Company is recalling the Bard MyPICC Kit 5F Dual-Lumen, Catalog Number CK000277. The recall involves 1,262 units of the product. The kits contain surgical gowns which were subject to a recall by the supplier.

The affected products were distributed to the following US states: Indiana, Missouri, Ohio, and Texas. The specific lot numbers involved are 18PB2134 and 19FBP619.

Consumers and healthcare facilities should stop using the affected Bard MyPICC Kits and contact Becton Dickinson & Company for further instructions.

The recalled product

Product: BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000277
Manufacturer: Becton Dickinson & Company
Category: Medical Device — PICC Kit
Hazard: supplier-recall
Affected units: 1,262

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)

Lot Numbers: 18PB2134 19FBP619

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 8 recalled by Becton Dickinson & Company 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 8 products in this recall →

Same manufacturer · Becton Dickinson & Company

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