Cardinal Health Presource Packs Recall Over CliniClean Pericare Wipes Contamination (Ref. 4a605e)

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 36 units of Presource Packs containing CliniClean Pericare Wipes in BD Urinary Catheter Trays due to potential lubricant contamination.

The full picture behind this FDA recall

This notice was issued by FDA on September 16, 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.

It is tempting to skim, check personal relevance, and move on. The better habit is confirming scope, source, and timestamp first, then reading this alongside related notices instead of drawing a conclusion from one record alone.

The original agency source is linked below so you can verify this record directly before acting on it. Its related labels are recall, product-safety, fda, 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 affects 36 units of the following product distributed nationwide in the United States:

  • KIT,GYN LAPAROSCOPY DH, Catalog Number: PBOCGLN17
  • Lot Number: NGKV3390
  • UDI-DI: 10198956345133 (each), 50198956345131 (case) Recall number Z-3094-2026. Classification: Class II.

What You Should Do

Consumers should follow instructions provided in the firm's notification letter regarding the affected products. Contact Cardinal Health 200, LLC for return or refund information.

Why This Matters

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

Source

FDA recall Z-3094-2026, event ID 99553.

Original source: FDA Official Notice ↗

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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.

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Cardinal Health 200, LLC is recalling 36 units of Presource Packs containing CliniClean Pericare Wipes in BD Urinary Catheter Trays due to potential lubricant 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.