Recall Weekly
Moderate riskFDA DeviceClass II

Cardinal Health Presource Packs with CliniClean Pericare Wipes recalled for manufacturing lubricant contamination

Presource Packs containing CliniClean Pericare Wipes in BD Urinary Catheter Trays may contain manufacturing lubricant residue on the wipes. 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 your urinary catheter trays for the affected catalog numbers: KIT BLO LAVH, KIT UMMC AB HYST II 170032, or TLH PACK.
  2. Do not use the wipes if your product matches one of the affected lot numbers: GKU1823 or NGKW2883.
  3. Contact Cardinal Health or your supplier for instructions on returning or replacing the affected packs.
Official notice ↗

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) PBCGLVBLI, Catalog Number: KIT, BLO LAVH ; 2) PB15HYFCY, Catalog Number: KIT, UMMC AB HYST II 170032 ; 3) SMA4FTLSCA, Catalog Number: TLH PACK
Sold in
Nationwide
Made for
Adults

This recall covers 12 products — see all of them.

Details

Units affected
175 units
Illnesses reported
None reported
Manufactured in
3651 Birchwood Dr, N/A, Waukegan, IL, United States
Classification
Class II
Recall number
Z-3103-2026

In the FDA's words

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 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) 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 Distribution: US Nationwide distribution. Affected quantity: 175 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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