Cardinal Health 200, LLC: Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, CHONY ORTHO MAJOR SPINE , Catalog Number: P
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Cardinal Health 200, LLC
- Product
- Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, CHONY ORTHO MAJOR SPINE , Catalog Number: POV2SCCPP; 2) KIT,ORTHOPLASTIC MICROVASCULAR, Catalog Number: PWVMFFABLI
- Reason / hazard
- 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution.
- Recall initiated
- 2026-07-29
- Code info
- 1) POV2SCCPP, UDI-DI: 10198956285200(each), 50198956285208(case), Lot Number: NGKV3390 ; 2) PWVMFFABLI, UDI-DI: 10198956123915(each), 50198956123913(case), Lot Number: NGKT2394
- Product quantity
- 44 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Waukegan
- State
- IL
- Country
- United States
- Event id
- 99553
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