Moderate riskFDA DeviceClass II

Cardinal Health Presource Packs with CliniClean wipes recalled for potential lubricant contamination

Urinary catheter trays in certain Cardinal Health Presource Packs contain CliniClean Pericare Wipes that may have been contaminated with lubricant from manufacturing. If used on a patient, the contaminated wipes could cause localized skin irritation, redness, or mild inflammation.

From the FDA notice · Read the official notice ↗ · All Cardinal Health recalls

What to do

  1. Check if you have affected trays (Catalog Numbers POV2SCCPP or PWVMFFABLI, Lot Numbers NGKV3390 or NGKT2394)
  2. Do not use the CliniClean Pericare Wipes from affected trays on patients
  3. Contact Cardinal Health or your supplier for instructions on replacement or return

Is yours affected?

Compare your label or packaging with the recalled product.

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
Sold in
Nationwide
Made for
Adults

This recall covers 12 products — see all of them.

Details

Units affected
44 units
Illnesses reported
None reported
Manufactured in
3651 Birchwood Dr, N/A, Waukegan, IL, United States
Classification
Class II
Recall number
Z-3105-2026

In the FDA's words

Description
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 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. 1) POV2SCCPP, UDI-DI: 10198956285200(each), 50198956285208(case), Lot Number: NGKV3390 ; 2) PWVMFFABLI, UDI-DI: 10198956123915(each), 50198956123913(case), Lot Number: NGKT2394 Distribution: US Nationwide distribution. Affected quantity: 44 units
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.

12 products in this recall

Cardinal Health catheter trays recalled for possible contamination

Cardinal Health is recalling 12 procedure kits that include BD Urinary Catheter Trays with CliniClean Pericare Wipes. The wipes may be contaminated with a lubricant used during manufacturing. If a contaminated wipe is used on a patient, it may cause localized skin irritation, redness, or mild inflammation. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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