FDA-Device2026-09-09Class IIPROCESSING DEFECT

Cardinal Health Presource Packs with CliniClean Pericare Wipes recalled for manufacturing lubricant contamination

OTHERNationwide distributionMedical devices

What this means

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

Check your facility's inventory against the affected lot numbers listed in the FDA notice.
Do not use affected Presource Packs or CliniClean Pericare Wipes from contaminated lots.
Contact Cardinal Health or your supplier for replacement stock.
Review patient records if contaminated wipes were used and monitor for skin irritation.

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

1398 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, BLO ROBOTIC GYN , Catalog Number: PBCGRGB28; 2) KIT , GYN MAJOR BARNES JEWIS, Catalog Number: PBVMLP22G; 3) KIT, GYN OPERATIVE LAPAROSCOPY, Catalog Number: PBVM0722D; 4) KIT,MAJOR VAGINAL,PRESBYTERIAN, Catalog Number: PBV2MJMVH; 5) KIT, GYN LAPAROSCOPY , Catalog Number: PBV2MJMVH; 6) KIT, GYN LAPAROSCOPY , Catalog Number: PB43LSEJG; 7) GYNE ROBOTIC PACK CMC , Catalog Number: SMACGGRACE; 8) LH GYN ROBOTICS PK , Catalog Number: SMAOCGYLHL; 9) DAVINCI PACK WOMENS , Catalog Number: SMAVPDWTMC; 10) PK GYN ROBOTICS OD , Catalog Number: SMA4JGRODB; 11) PK LAPAROSCOPY GYN OD , Catalog Number: SMA4JLGODA

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3101-2026

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 wipes recalled for potential lubricant contamination

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