CLASS II ONGOING Device recall · Reported 9 Sep 2026 · FDA Enforcement Report

Presource Packs Containing CliniClean Pericare Wipes within recalled

Cardinal Health 200 is recalling Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays, distributed nationwide in the US. The recall was initiated on 29 Jul 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1) PNCGCNAUM, UDI-DI: 10197106894316(each), 50197106894314(case), Lot Number: NGKT2391 ; 2) PNCGCNAUM, UDI-DI: 10197106894316(each), 50197106894314(case), Lot Number: NGKT2455 ; 3) PNHDFSVCI, UDI-DI: 10198956143470(each), 50198956143478(case), Lot Number: NGKU1022 ; 4) PNHDFSVCI, UDI-DI: 10198956143470(each), 50198956143478(case), Lot Number: NGKU1022 ; 5) PNHDOTVCQ, UDI-DI: 10198956143777(each), 50198956143775(case), Lot Number: NGKU1022 ; 6) PNHDOTVCQ, UDI-DI: 10198956143777(each), 50198956143775(case), Lot Number: NGKU1022 ; 7) PNHDOTVCQ, UDI-DI: 10198956143777(each), 50198956143775(case), Lot Number: NGKU1022 ; 8) PNV20101L, UDI-DI: 10198956285217(each), 50198956285215(case), Lot Number: NGKV3390 ; 9) PNV20101L, UDI-DI: 10198956285217(each), 50198956285215(case), Lot Number: NGKV2390 ; 10) PNV20101L, UDI-DI: 10198956285217(each), 50198956285215(case), Lot Number: NGKV2390 ; 11) PN15LSRMH, UDI-DI: 10198956341692(each), 50198956341690(case), Lot Number: NGKW3769 ; 12) SNECGLFABB, UDI-DI: 10197106881675(each), 50197106881673(case), Lot Number: NGKU0856 ; 13) SNEOCGSLHP, UDI-DI: 10198956233430(each), 50198956233438(case), Lot Number: NGKW3769 ; 14) SNEOCGSLHP, UDI-DI: 10198956233430(each), 50198956233438(case), Lot Number: NGKW3769 ; 15) SNEOCGSL20, UDI-DI: 10198956305762(each), 50198956305760(case), Lot Number: NGKW0682 ; 16) SNEOCGSL20, UDI-DI: 10198956305762(each), 50198956305760(case), Lot Number: NGKW3769

Quantity recalled645 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-3104-2026
FDA event ID: 99553
Recalling firm: Cardinal Health 200, Waukegan, IL
Classification: Class II
Status: Ongoing
Recall initiated: 29 Jul 2026
FDA classified: 3 Sep 2026
Reported: 9 Sep 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

29 Jul 2026	Recall initiated by company
3 Sep 2026	Classified by FDA	+36 days
9 Sep 2026	Published in enforcement report	+6 days

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

Reason for recall

The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation.

Product as listed by the FDA

Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ASLMC CRANIOTOMY , Catalog Number: PNCGCNAUM; 2) KIT, ORP MAJOR SPINE , Catalog Number: PNHDFSVCI; 3) KIT,ORP NEURO TRAUMA , Catalog Number: PNHDOTVCQ; 4) KIT, CRANIOTOMY PRESBYTERIAN , Catalog Number: PNV20101L; 5) KIT, LARGE SPINE 143487 , Catalog Number: PNV20101L; 6) FUSION ACCESSORY PACK BRO , Catalog Number: SNECGLFABB; 7) LH GENERAL NEURO SPINE PACK , Catalog Number: SNEOCGSLHP; 8) LH GENERAL NEURO SPINE PACK , Catalog Number: SNEOCGSL20

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Is Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays recalled?

Yes. Cardinal Health 200 recalled Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays on 29 Jul 2026. The recall is Class II and its status is Ongoing. Recall number Z-3104-2026.

Why was it recalled?

Which lots are affected?

1) PNCGCNAUM, UDI-DI: 10197106894316(each), 50197106894314(case), Lot Number: NGKT2391 ; 2) PNCGCNAUM, UDI-DI: 10197106894316(each), 50197106894314(case), Lot Number: NGKT2455 ; 3) PNHDFSVCI, UDI-DI: 10198956143470(each), 50198956143478(case), Lot Number: NGKU1022 ; 4) PNHDFSVCI, UDI-DI: 10198956143470(each), 50198956143478(case), Lot Number: NGKU1022 ; 5) PNHDOTVCQ, UDI-DI: 10198956143777(each), 50198956143775(case), Lot Number: NGKU1022 ; 6) PNHDOTVCQ, UDI-DI: 10198956143777(each), 50198956143775(case), Lot Number: NGKU1022 ; 7) PNHDOTVCQ, UDI-DI: 10198956143777(each), 50198956143775(case), Lot Number: NGKU1022 ; 8) PNV20101L, UDI-DI: 10198956285217(each), 50198956285215(case), Lot Number: NGKV3390 ; 9) PNV20101L, UDI-DI: 10198956285217(each), 50198956285215(case), Lot Number: NGKV2390 ; 10) PNV20101L, UDI-DI: 10198956285217(each), 50198956285215(case), Lot Number: NGKV2390 ; 11) PN15LSRMH, UDI-DI: 10198956341692(each), 50198956341690(case), Lot Number: NGKW3769 ; 12) SNECGLFABB, UDI-DI: 10197106881675(each), 50197106881673(case), Lot Number: NGKU0856 ; 13) SNEOCGSLHP, UDI-DI: 10198956233430(each), 50198956233438(case), Lot Number: NGKW3769 ; 14) SNEOCGSLHP, UDI-DI: 10198956233430(each), 50198956233438(case), Lot Number: NGKW3769 ; 15) SNEOCGSL20, UDI-DI: 10198956305762(each), 50198956305760(case), Lot Number: NGKW0682 ; 16) SNEOCGSL20, UDI-DI: 10198956305762(each), 50198956305760(case), Lot Number: NGKW3769

Where was it sold?

US Nationwide distribution.

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.

More recalls from Cardinal Health 200

All 283

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Presource Packs Containing CliniClean Pericare Wipes within recalled	Cardinal Health 200	Other	Nationwide
9 Sep 2026Device	CLASS II	Presource Packs Containing CliniClean Pericare Wipes within recalled	Cardinal Health 200	Other	Nationwide
9 Sep 2026Device	CLASS II	Presource Packs Containing CliniClean Pericare Wipes within recalled	Cardinal Health 200	Other	Nationwide
9 Sep 2026Device	CLASS II	Presource Packs Containing CliniClean Pericare Wipes within recalled	Cardinal Health 200	Other	Nationwide
9 Sep 2026Device	CLASS II	Presource Packs Containing CliniClean Pericare Wipes within recalled	Cardinal Health 200	Other	Nationwide

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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