Cardinal Health Presource Packs Recall Over CliniClean Pericare Wipes Contamination (Ref. 72f870)

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 645 units of Presource Packs containing CliniClean Pericare Wipes within BD Urinary Catheter Trays due to potential lubricant contamination that may cause skin irritation.

What this FDA recall tells you, and what most readers miss

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.

Before acting, the primary agency source is available to check alongside this summary. Its related labels are recall, product-safety, fda, Medical 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 involves 645 units distributed nationwide under the following catalog numbers and lot numbers: 1) KIT, ASLMC CRANIOTOMY (PNCGCNAUM, Lot NGKT2391, NGKT2455); 2) KIT, ORP MAJOR SPINE (PNHDFSVCI, Lot NGKU1022); 3) KIT,ORP NEURO TRAUMA (PNHDOTVCQ, Lot NGKU1022); 4) KIT, CRANIOTOMY PRESBYTERIAN (PNV20101L, Lot NGKV3390, NGKV2390); 5) KIT, LARGE SPINE 143487 (PNV20101L, Lot NGKV3390, NGKV2390); 6) FUSION ACCESSORY PACK BRO (SNECGLFABB, Lot NGKU0856); 7) LH GENERAL NEURO SPINE PACK (SNEOCGSLHP, Lot NGKW3769); 8) LH GENERAL NEURO SPINE PACK (SNEOCGSL20, Lot NGKW0682, NGKW3769). UDI-DI codes are provided in the recall notice.

What You Should Do

The recall was initiated voluntarily by the firm via letter. Healthcare facilities should identify and quarantine affected units.

Why This Matters

This Class II recall affects 645 units distributed across the United States and involves a potential for localized skin irritation from contaminated wipes.

Source

FDA recall number Z-3104-2026, 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.

Questions & Answers

What people usually ask about a notice like this one.

What is this FDA recall about?
Cardinal Health 200, LLC is recalling 645 units of Presource Packs containing CliniClean Pericare Wipes within 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.