Cardinal Health 200, LLC — Class II: Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1)
Cardinal Health 200, LLC has initiated a Class II recall for specific Presource Packs containing BD Urinary Catheter Trays due to potential contamination of CliniClean Pericare Wipes with a manufacturing lubricant. Use of the contaminated wipes may result in localized skin irritation, erythema, or mild inflammation.
This recall affects Cardinal Health 200, LLC, healthcare facilities utilizing specific BD Urinary Catheter Tray kits, and clinical staff responsible for catheterization procedures and inventory management.
The contamination of a component within a kitted tray highlights risks associated with complex supply chains and third-party component integration. For regulatory professionals, this underscores the importance of supplier quality controls and the potential for a localized manufacturing issue to trigger recalls across multiple finished product configurations (kits). The 'Ongoing' status suggests that reconciliation of affected units is still in progress.
QA and procurement teams should immediately identify and quarantine affected Presource Packs and BD Urinary Catheter Trays based on the catalog numbers provided. Regulatory teams should monitor for further updates regarding the scope of the manufacturing lubricant contamination and assess if other kitted products utilizing CliniClean wipes are impacted.
Class II. 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.. Product: 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. Firm: Cardinal Health 200, LLC (Waukegan IL United States). Status: Ongoing.
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