CLASS III Device recall · Reported 11 Nov 2015 · FDA Enforcement Report

Antibacterial Hydro Personal Catheter, Male, Product recalled

C.R. Bard is recalling Antibacterial Hydro Personal Catheter, Male, distributed nationwide in the US. The recall was initiated on 2 Oct 2015 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot 53620131

Quantity recalled4,170 each

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-0198-2016
FDA event ID: 72398
Recalling firm: C.R. Bard, Covington, GA
Classification: Class III
Status: Terminated
Recall initiated: 2 Oct 2015
FDA classified: 2 Nov 2015
Reported: 11 Nov 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Heart & Vascular Devices

Timeline

2 Oct 2015	Recall initiated by company
2 Nov 2015	Classified by FDA	+31 days
11 Nov 2015	Published in enforcement report	+9 days

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

Reason for recall

Incorrect unit labeling. The case label and shelf box are correct, Product Code 63512 and Catheter Size 12 French. The unit label (catheter package) may state Product Code 63516 and Catheter Size 16 French.

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

Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units

Where it was distributed

Nationwide Distribution including CA, FL, IL, MO, NJ, OR, PA, TX & WA.

Nationwide California Florida Illinois Missouri New Jersey Oregon Pennsylvania Texas Washington

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot 53620131

Where was it sold?

Nationwide Distribution including CA, FL, IL, MO, NJ, OR, PA, TX & WA.

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from C.R. Bard

All 123

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Temperature Abuse	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Temperature Abuse	Nationwide

Other Heart & Vascular Devices recalls

All 6,199

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide