CLASS II Device recall · Reported 28 Apr 2021 · FDA Enforcement Report

Bard Clean-Cath Intermittent Catheter female length recalled

C.R. Bard is recalling Bard Clean-Cath Intermittent Catheter female length (catheter, urological), distributed nationwide in the US. The recall was initiated on 11 Jan 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCat. No. 420712/Lot No. NGDY1813/ UDI (GTIN) (01)00801741038730(17)241130(10), Exp. Date 11/30/2024

Quantity recalled9,800 Units

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-1431-2021
FDA event ID: 87163
Recalling firm: C.R. Bard, Covington, GA
Classification: Class II
Status: Terminated
Recall initiated: 11 Jan 2021
FDA classified: 16 Apr 2021
Reported: 28 Apr 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Heart & Vascular Devices

Timeline

11 Jan 2021	Recall initiated by company
16 Apr 2021	Classified by FDA	+95 days
28 Apr 2021	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

The device catheter tip was cut off (no tip) and the product packaging was not fully sealed.

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

Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, urological) - Product Usage: for urological use only.

Where it was distributed

Worldwide distribution - US Nationwide distribution and the countries of Australia, Canada.

Nationwide

Questions about this recall

Is Bard Clean-Cath Intermittent Catheter female length (catheter, urological) recalled?

Yes. C.R. Bard recalled Bard Clean-Cath Intermittent Catheter female length (catheter, urological) on 11 Jan 2021. The recall is Class II and its status is Terminated. Recall number Z-1431-2021.

Why was it recalled?

The device catheter tip was cut off (no tip) and the product packaging was not fully sealed.

Which lots are affected?

Cat. No. 420712/Lot No. NGDY1813/ UDI (GTIN) (01)00801741038730(17)241130(10), Exp. Date 11/30/2024

Where was it sold?

Worldwide distribution - US Nationwide distribution and the countries of Australia, Canada.

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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