Cardinal Health Presource Packs Recall Over CliniClean Pericare Wipes Contamination (Ref. aa1627)

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 19 units of Presource Packs with CliniClean Pericare Wipes in BD Urinary Catheter Trays due to potential lubricant contamination that may cause skin irritation.

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.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.

Before acting, the primary agency source is available to check alongside this summary. Its related labels are recall, product-safety, fda, Devices.

What Happened

Cardinal Health 200, LLC is recalling 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 19 units of the following product distributed nationwide in the United States:

  • KIT, LUNG TX CIRCULATOR, Catalog Number: OVC3507231
  • Lot Number: NGKU0957
  • UDI-DI: 10198956232457 (each), 50198956232455 (case)

Recall number Z-3096-2026. Classification: Class II.

What You Should Do

Consumers and healthcare facilities should immediately stop using the affected products and follow the instructions provided in the firm's notification letter for return or disposal. Contact Cardinal Health for further guidance on returns or refunds.

Why This Matters

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

Source

FDA Recall Z-3096-2026 - Cardinal Health 200, LLC, Waukegan, IL

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.

Questions & Answers

What people usually ask about a notice like this one.

What is this FDA recall about?
Cardinal Health is recalling 19 units of Presource Packs with 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.