Cardinal Health Presource Packs Recall Over CliniClean Pericare Wipes Contamination (Ref. 5343b4)
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Cardinal Health is recalling 60 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 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.
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.
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 because 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, including irritation, erythema, or mild inflammation.
Which Products Are Affected
The recall affects 60 units of the following product distributed nationwide:
- KIT,MAXILLOFACIAL PRESBYTERIAN, Catalog Number: PWV2MF01D
- Lot Number: NGKV3390
- UDI-DI: 10198956285255 (each), 50198956285253 (case)
Recall number: Z-3099-2026. Classification: Class II.
What You Should Do
Healthcare providers and facilities should discontinue use of the affected lots and contact Cardinal Health for return or additional instructions regarding the recalled products.
Why This Matters
Use of potentially contaminated wipes may result in localized skin irritation, erythema, or mild inflammation in patients.
Source
FDA recall Z-3099-2026, Event ID 99553. Recalling firm: Cardinal Health 200, LLC, Waukegan, IL.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Medline Convenience Kits Recall Over ChloraPrep Applicator Sterility Breach (Ref. 2fe0d4)
FDA · September 16, 2026
Cardinal Health Presource Packs Recall Over CliniClean Pericare Wipes Contamination (Ref. 1adab6)
FDA · September 16, 2026
Medline Convenience Kits Recall Over BD ChloraPrep Applicator Seal Issue (Ref. 929d71)
FDA · September 16, 2026
Elsewhere in the country: similar length or severity timing 8
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