FDA-Device2026-09-09Class IIPROCESSING DEFECT
Cardinal Health surgical kits recalled for contaminated CliniClean pericare wipes
Nationwide distributionMedical devices
What this means
Cardinal Health surgical kits containing CliniClean Pericare Wipes may have wipes contaminated with manufacturing lubricant. If used on patients, the wipes could cause localized skin irritation, redness, or mild inflammation.
- Check if your facility received any of the affected kits (catalog numbers PNCGCNAUM, PNHDFSVCI, PNHDOTVCQ, PNV20101L, PN15LSRMH, SNECGLFABB, SNEOCGSLHP, or SNEOCGSL20).
- Do not use CliniClean Pericare Wipes from affected kits.
- Contact Cardinal Health or the FDA with questions about your specific lot number.
The agency's original wording
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
645 units
Manufactured in
3651 Birchwood Dr, N/A, Waukegan, IL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3104-2026More Cardinal Health recalls
- FDA-Device2026-09-09Cardinal Health Presource Packs with CliniClean Pericare Wipes recalled for manufacturing lubricant contamination
- FDA-Device2026-09-09Cardinal Health Presource Packs with CliniClean Pericare Wipes recalled for potential lubricant contamination
- FDA-Device2026-09-09Cardinal Health CliniClean Pericare Wipes in BD urinary catheter trays recalled for potential lubricant contamination
- FDA-Device2026-09-09Cardinal Health CliniClean Pericare Wipes in BD Urinary Catheter Trays recalled for lubricant contamination
- FDA-Device2026-09-09Cardinal Health Presource Packs with CliniClean Pericare Wipes recalled for manufacturing lubricant contamination
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