FDAFDA · Food and drugs·Recall number Z-3104-2026
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
Published September 9, 2026 · Recall initiated: July 29, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cardinal Health 200, LLC
- Distributor
- US Nationwide distribution.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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