Cardinal Health Presource Packs Recall Over CliniClean Pericare Wipes Contamination

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

Cardinal Health is recalling 175 units of Presource Packs containing CliniClean Pericare Wipes in BD Urinary Catheter Trays due to potential lubricant contamination that may cause skin irritation.

FDA recall: what the record actually shows

This notice was issued by FDA on September 14, 2026 and geographically references United States. The FDA classifies this as a Class II recall, with the stated reason "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.", distributed us nationwide distribution.. FDA recall classes run from I (reasonable probability of serious harm) to III (unlikely to cause harm), so the class number is the fastest way to gauge severity here. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

A quick skim tells you whether this affects you directly; a closer read tells you more. Check the scope, the source, and how recent the record is, then weigh it against related notices rather than treating any single one as a trend.

Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-devices.

What Happened

Cardinal Health 200, LLC initiated a voluntary recall of Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays. The trays contain 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, including irritation, erythema, or mild inflammation.

Which Products Are Affected

The recall covers 175 units distributed nationwide in the United States under the following catalog numbers and lot numbers:

  • PBCGLVBLI (Catalog Number: KIT, BLO LAVH), Lot Number: GKU1823, UDI-DI: 10198956055469 (each), 50198956055467 (case)
  • PB15HYFCY (Catalog Number: KIT, UMMC AB HYST II 170032), Lot Number: NGKW2883, UDI-DI: 10197106474877 (each), 50197106474875 (case)
  • SMA4FTLSCA (Catalog Number: TLH PACK), Lot Number: GKU1823, UDI-DI: 10197106609880 (each), 50197106609888 (case)

This is FDA Class II recall number Z-3103-2026.

What You Should Do

Healthcare providers and facilities should identify and quarantine affected products. Contact Cardinal Health 200, LLC for return or further instructions regarding the recalled items.

Why This Matters

Use of the potentially contaminated wipes may result in localized skin irritation, erythema, or mild inflammation for patients.

Source

FDA recall Z-3103-2026, Cardinal Health 200, LLC, Waukegan, IL.

Original source: FDA Official Notice ↗

All FDA Recalls →

Comparable nationwide notices (length or severity timing) 8

Beyond this FDA recall's own category, Areazine surfaces two nationwide peer sets: length-matched and severity/date-matched notices from elsewhere in the archive, distinct from the same-feed Related list above.

What People Ask

Common questions about this FDA recall.

What is this FDA recall about?
Cardinal Health is recalling 175 units of Presource Packs containing CliniClean Pericare Wipes in BD Urinary Catheter Trays due to potential lubricant contamination that may cause skin irritation.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How is this recall classified, and why does that matter?
The FDA classifies this as a Class II recall, citing "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." as the reason. Class I is the most serious (reasonable probability of serious harm), Class II is a moderate or temporary health risk, and Class III is unlikely to cause harm.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.