CLASS II Device recall · Reported 20 May 2020 · FDA Enforcement Report

PowerGlide ST Midline Catheter Maximal Barrier Kit- length recalled

Becton Dickinson & is recalling PowerGlide ST Midline Catheter Maximal Barrier Kit- length, distributed in 14 states. The recall was initiated on 17 Mar 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: REDW0476 20 Exp. Date: 20OCT30 UDI: (01)00801741139390

Quantity recalled655 kits

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-1946-2020
FDA event ID: 85287
Recalling firm: Becton Dickinson &, Franklin Lakes, NJ
Classification: Class II
Status: Terminated
Recall initiated: 17 Mar 2020
FDA classified: 8 May 2020
Reported: 20 May 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Heart & Vascular Devices

Timeline

17 Mar 2020	Recall initiated by company
8 May 2020	Classified by FDA	+52 days
20 May 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

Iincorrectly packaged without the required lidocaine as labeled

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

PowerGlide ST Midline Catheter Maximal Barrier Kit-18 gauge,10 cm length Catalog Number: ST018101D

Where it was distributed

AZ, CT, GA, IL, LA, MA, MI, MN, ND, NE, NY, OH, SD, TX),

Arizona Connecticut Georgia Illinois Louisiana Massachusetts Michigan Minnesota North Dakota Nebraska New York Ohio South Dakota Texas

Questions about this recall

Is PowerGlide ST Midline Catheter Maximal Barrier Kit- length recalled?

Yes. Becton Dickinson & recalled PowerGlide ST Midline Catheter Maximal Barrier Kit- length on 17 Mar 2020. The recall is Class II and its status is Terminated. Recall number Z-1946-2020.

Why was it recalled?

Iincorrectly packaged without the required lidocaine as labeled

Which lots are affected?

Lot Number: REDW0476 20 Exp. Date: 20OCT30 UDI: (01)00801741139390

Where was it sold?

AZ, CT, GA, IL, LA, MA, MI, MN, ND, NE, NY, OH, SD, TX),

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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