FDA-Device2026-09-09Class IIPROCESSING DEFECT

Cardinal Health Presource Packs with CliniClean Pericare Wipes recalled for contaminated lubricant in BD catheter trays

OTHERNationwide distributionMedical devices

What this means

Certain surgical kits containing CliniClean Pericare Wipes in BD Urinary Catheter Trays may have residual manufacturing lubricant on the wipes. If used on a patient, the contaminated wipes could cause localized skin irritation, redness, or mild inflammation.

Check if your facility has affected kits using the catalog numbers and lot numbers in the recall notice
Do not use affected wipes on patients
Return or dispose of affected kits according to your facility's protocols
Contact Cardinal Health or the FDA with questions about specific lot numbers

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

846 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, GYN ROBOTIC GSAM , Catalog Number: PBCCGRSGD; 2) KIT, GYN ROBOT ACCESSORY , Catalog Number: PB35GYBJC; 3) KIT, PRIMARY RESECTION , Catalog Number: PGVMOTBB19; 4) KIT, LIVER TRANSPLANT SUPPORT , Catalog Number: PGVM07C26; 5) KIT, LIVER TRANSPLANT SUPPORT , Catalog Number: PGVM07C26; 6) KIT, LIVER TRANSPLANT SUPPORT , Catalog Number: PGV2LTNHN; 7) KIT,UMMC GENERAL MAJOR TRANSPL, Catalog Number: PG15OT92A; 8) KIT,MAJOR LITHOTOMY NEW HAN , Catalog Number: PG23MLNLD; 9) KIT, GENDER CARE , Catalog Number: PG29GCPCK; 10) KIT, GENDER CARE , Catalog Number: PG29GCPC3; 11) KIT, MUH LIVER , Catalog Number: PG33LVMNC; 12) KIT, MIS HERNIA , Catalog Number: PG35HPBJK; 13) KIT, GENERAL MAJOR , Catalog Number: PG43MJEJD; 14) KIT, OPEN THORACOTOMY CMC , Catalog Number: PVCGOTACF; 15) KIT, MER THORACOTOMY ABDOMINAL, Catalog Number: PVX4TAMYB; 16) KIT, MER THORACOTOMY ABDOMINAL, Catalog Number: PVX4TAMYC; 17) KIT, HEART II , Catalog Number: PV23HEVAE; 18) KIT, FLAP ACCESSORY , Catalog Number: PW35FABJE; 19) HMC ROBOTIC PACK , Catalog Number: SBA23RBHNG; 20) HMC ROBOTIC PACK , Catalog Number: SBA23RBHNH

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3095-2026

More Cardinal Health recalls

FDA-Device2026-09-09
Cardinal Health Presource Packs with CliniClean Pericare Wipes recalled for manufacturing lubricant contamination
FDA-Device2026-09-09
Cardinal Health Presource Packs with CliniClean Pericare Wipes recalled for potential lubricant contamination
FDA-Device2026-09-09
Cardinal Health CliniClean Pericare Wipes in BD urinary catheter trays recalled for potential lubricant contamination
FDA-Device2026-09-09
Cardinal Health CliniClean Pericare Wipes in BD Urinary Catheter Trays recalled for lubricant contamination
FDA-Device2026-09-09
Cardinal Health Presource Packs with CliniClean Pericare Wipes recalled for manufacturing lubricant contamination

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