CLASS II Device recall · Reported 4 Nov 2020 · FDA Enforcement Report

Bard 3F SL PowerMidline Basic Kit CE-indicated recalled

Becton Dickinson & is recalling Bard 3F SL PowerMidline Basic Kit CE-indicated for short term access to the peripheral. The recall was initiated on 14 Sep 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: REEP2920 Exp. Date: Jan-2022 UDI: 00801741141027

Quantity recalled45 units OUS only

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0294-2021
FDA event ID: 86477
Recalling firm: Becton Dickinson &, Franklin Lakes, NJ
Classification: Class II
Status: Terminated
Recall initiated: 14 Sep 2020
FDA classified: 23 Oct 2020
Reported: 4 Nov 2020
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Lead & Heavy Metals
Device type: Other Medical Devices

Timeline

14 Sep 2020	Recall initiated by company
23 Oct 2020	Classified by FDA	+39 days
4 Nov 2020	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Kits do not contain the stylet/T-lock assembly indicated as a component on the label, may lead to a procedural delay and possibly discard of the kit.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

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

Where it was distributed

Foreign: Italy, Spain, and UK

Questions about this recall

Is Bard 3F SL PowerMidline Basic Kit CE-indicated for short term access to the peripheral recalled?

Yes. Becton Dickinson & recalled Bard 3F SL PowerMidline Basic Kit CE-indicated for short term access to the peripheral on 14 Sep 2020. The recall is Class II and its status is Terminated. Recall number Z-0294-2021.

Why was it recalled?

Kits do not contain the stylet/T-lock assembly indicated as a component on the label, may lead to a procedural delay and possibly discard of the kit.

Which lots are affected?

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

Where was it sold?

Foreign: Italy, Spain, and UK

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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