Cardinal Health Presource Packs Recall Over CliniClean Pericare Wipes Contamination (Ref. c891b0)

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 200, LLC is recalling 115 units of Presource Packs containing CliniClean Pericare Wipes in BD Urinary Catheter Trays due to potential contamination.

Reading this FDA recall beyond the headline

This notice was issued by FDA on September 15, 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, Devices.

What Happened

Cardinal Health 200, LLC initiated a voluntary recall of certain Presource Packs containing CliniClean Pericare Wipes within BD Urinary Catheter Trays. The trays may contain wipes potentially contaminated with a lubricant from the manufacturing process, which could cause localized skin effects including irritation, erythema, or mild inflammation if used on a patient.

Which Products Are Affected

The recall affects 115 units distributed nationwide in the United States under the following catalog and lot numbers:

  • KIT,ROBOTICS DH (Catalog Number: PGOCRDNHD, Lot Number: NGKV3390, UDI-DI: 10198956057012 each / 50198956057010 case)
  • KIT, EAS ROBOTIC (Catalog Number: PG36RPEAB, Lot Number: NGKU2052, UDI-DI: 10198956225091 each / 50198956225099 case)
  • KIT, VIDEO THORACOSCOPY CMC (Catalog Number: PVCGVTACF, Lot Number: NGKV3487, UDI-DI: 10195594816568 each / 50195594816566 case)

This is FDA Class II recall Z-3097-2026, initiated July 29, 2026.

What You Should Do

Consumers and healthcare facilities should stop using the affected products and contact Cardinal Health for return or refund instructions.

Why This Matters

Use of the potentially contaminated wipes could result in localized skin irritation or inflammation in patients.

Source

FDA recall number Z-3097-2026

Original source: FDA Official Notice ↗

All FDA Recalls →

Similar notices nationwide by 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.

Common Questions

Common questions about this FDA recall.

What is this FDA recall about?
Cardinal Health 200, LLC is recalling 115 units of Presource Packs containing CliniClean Pericare Wipes in BD Urinary Catheter Trays due to potential contamination.
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.