Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) PBCGLVBLI, Catalog Number: KI
Summary
The FDA issued a Class II for Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter by Cardinal Health 200, LLC. Reason: The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing proc.
Details
Source
Device Recall
External ID
Z-3103-2026
Action Date
2026-09-09
Status
Ongoing
Category
device
Product Description
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) PBCGLVBLI, Catalog Number: KIT, BLO LAVH ; 2) PB15HYFCY, Catalog Number: KIT, UMMC AB HYST II 170032 ; 3) SMA4FTLSCA, Catalog Number: TLH PACK
Lot/Code Info: 1) PBCGLVBLI, UDI-DI: 10198956055469(each), 50198956055467(case), Lot Number: GKU1823 ; 2) PB15HYFCY, UDI-DI: 10197106474877(each), 50197106474875(case), Lot Number: NGKW2883 ; 3) PB15HYFCY, UDI-DI: 10197106474877(each), 50197106474875(case), Lot Number: NGKW2883 ; 4) PB15HYFCY, UDI-DI: 10197106474877(each), 50197106474875(case), Lot Number: NGKW2883 ; 5) SMA4FTLSCA, UDI-DI: 10197106609880(each), 50197106609888(case), Lot Number: GKU1823
Quantity Affected: 175 units
Reason for Recall
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.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-29
Company
Waukegan, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 183 device recalls issued in the same week, part of 445 device-related FDA actions this month.
Cardinal Health 200, LLC has 164 FDA actions in our database, including 163 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Cardinal Health 200, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cardinal Health 200, LLC have FDA actions?
Cardinal Health 200, LLC has 164 FDA actions in our database, including 163 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3103-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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