The Recall Desk
ModerateFDA (Devices)·Z-0294-2021·Announced 2020-11-04

Bard 3F SL PowerMidline Kit Recalled for Missing Stylet Assembly

Becton Dickinson is recalling 45 Bard 3F SL PowerMidline kits in Italy, Spain, and the UK because they lack the stylet/T-lock assembly listed on the label.

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, but the hazard is limited to a missing component causing procedural delay or kit discard, with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Becton Dickinson & Company is recalling 45 units of the Bard 3F SL PowerMidline Basic Kit (Ref: P6153118). The affected kits are identified by Lot Number REEP2920 and an expiration date of January 2022. The recall is limited to units distributed in Italy, Spain, and the United Kingdom.

The recall was initiated because the kits do not contain the stylet/T-lock assembly, which is indicated as a component on the product label. The absence of this component may lead to a procedural delay and possibly the discard of the kit. No injuries or illnesses have been reported in connection with this recall.

Healthcare facilities and distributors in the affected regions should stop using the identified kits and contact Becton Dickinson for further instructions. Consumers should not use these kits if they have them in their possession.

The recalled product

Product
Bard 3F SL PowerMidline Basic Kit CE-indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media Ref: P6153118
Affected units
45

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 Number: REEP2920 Exp. Date: Jan-2022 UDI: 00801741141027

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 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 2 products in this recall →