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Presource Packs Containing CliniClean Pericare Wipes within… recallZ-3095-2026 · Cardinal Health 200, LLC · initiated Jul 29, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Cardinal Health 200, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Process change control

What the company is doing

An URGENT: PRODUCT CORRECTION notification letter dated 7/29/26 was sent to customers. If you locate affected product within your facility, please do the following: 1. QUARANTINE affected kits. 2. ALERT your clinicians of this action. 3. AFFIX a WARNING LABEL to the front of each Presource kit so that it is clearly visible to clinicians, instructing them to remove and discard the recalled component(s). 4. RETURN a copy of the enclosed Acknowledgment Form confirming your receipt of this action and the completion of labeling product via fax to 614.652.9648. Additional labels will be sent to your facility upon request. Please send an email to: [email protected] For component credit or replacement, please contact the following: " Hospitals Cardinal Customer Service at 866.551.0533 " Distributors Distributor Management at 800.635.6021 " Federal Government facilities Government Customer Service at 800.444.1166 If you are a Distributor and have further distributed affected kits please notify your customers of this recall. We sincerely apologize for any inconvenience this notice may have caused you and your staff. Should you have any questions, require additional labels or desire special assistance relating to this recall, please feel free to contact Cardinal Health Quality Systems at 800.292.9332.

Recall details

Recall number
Z-3095-2026
Status
Open, Classified
Initiated by the company
Jul 29, 2026
Posted by the FDA
Sep 3, 2026
Recalling firm
Cardinal Health 200, LLC
Quantity
846 units
Product code
LRO
Distribution
US Nationwide distribution.

Product description

Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, GYN ROBOTIC GSAM , Catalog Number: PBCCGRSGD; 2) KIT, GYN ROBOT ACCESSORY , Catalog Number: PB35GYBJC; 3) KIT, PRIMARY RESECTION , Catalog Number: PGVMOTBB19; 4) KIT, LIVER TRANSPLANT SUPPORT , Catalog Number: PGVM07C26; 5) KIT, LIVER TRANSPLANT SUPPORT , Catalog Number: PGVM07C26; 6) KIT, LIVER TRANSPLANT SUPPORT , Catalog Number: PGV2LTNHN; 7) KIT,UMMC GENERAL MAJOR TRANSPL, Catalog Number: PG15OT92A; 8) KIT,MAJOR LITHOTOMY NEW HAN , Catalog Number: PG23MLNLD; 9) KIT, GENDER CARE , Catalog Number: PG29GCPCK; 10) KIT, GENDER CARE , Catalog Number: PG29GCPC3; 11) KIT, MUH LIVER , Catalog Number: PG33LVMNC; 12) KIT, MIS HERNIA , Catalog Number: PG35HPBJK; 13) KIT, GENERAL MAJOR , Catalog Number: PG43MJEJD; 14) KIT, OPEN THORACOTOMY CMC , Catalog Number: PVCGOTACF; 15) KIT, MER THORACOTOMY ABDOMINAL, Catalog Number: PVX4TAMYB; 16) KIT, MER THORACOTOMY ABDOMINAL, Catalog Number: PVX4TAMYC; 17) KIT, HEART II , Catalog Number: PV23HEVAE; 18) KIT, FLAP ACCESSORY , Catalog Number: PW35FABJE; 19) HMC ROBOTIC PACK , Catalog Number: SBA23RBHNG; 20) HMC ROBOTIC PACK , Catalog Number: SBA23RBHNH

Code information (models, lots, serial numbers)

Show the full code information (4k characters)

1) PBCCGRSGD, UDI-DI: 10197106840085(each), 50197106840083(case), Lot Number: NGKU0957 ; 2) PB35GYBJC, UDI-DI: 10197106375723(each), 50197106375721(case), Lot Number: NGKU2052 ; 3) PGVMOTBB19, UDI-DI: 10198956264113(each), 50198956264111(case), Lot Number: NGKT2394 ; 4) PGVM07C26, UDI-DI: 10198956264434(each), 50198956264432(case), Lot Number: NGKT2394 ; 5) PGVM07C27, UDI-DI: 10198956292895(each), 50198956292893(case), Lot Number: NGKT2394 ; 6) PGV2LTNHN, UDI-DI: 10198956292499(each), 50198956292497(case), Lot Number: NGKV2390 ; 7) PGV2LTNHN, UDI-DI: 10198956292499(each), 50198956292497(case), Lot Number: NGKV3390 ; 8) PG15OT92A, UDI-DI: 10197106475041(each), 50197106475049(case), Lot Number: NGKW2883 ; 9) PG23MLNLD, UDI-DI: 10198956432024(each), 50198956432022(case), Lot Number: NGKU3969 ; 10) PG29GCPCK, UDI-DI: 10198956299207(each), 50198956299205(case), Lot Number: NGKU4716 ; 11) PG29GCPC3, UDI-DI: 10198956532496(each), 50198956532494(case), Lot Number: NGKU4716 ; 12) PG33LVMNC, UDI-DI: 10198956188358(each), 50198956188356(case), Lot Number: NGKU1994 ; 13) PG33LVMNC, UDI-DI: 10198956188358(each), 50198956188356(case), Lot Number: NGKU1994 ; 14) PG33LVMNC, UDI-DI: 10198956188358(each), 50198956188356(case), Lot Number: NGKU1994 ; 15) PG33LVMNC, UDI-DI: 10198956188358(each), 50198956188356(case), Lot Number: NGKU1994 ; 16) PG35HPBJK, UDI-DI: 10198956124110(each), 50198956124118(case), Lot Number: NGKU0856 ; 17) PG35HPBJK, UDI-DI: 10198956124110(each), 50198956124118(case), Lot Number: NGKU0957 ; 18) PG35HPBJK, UDI-DI: 10198956124110(each), 50198956124118(case), Lot Number: NGKU0957 ; 19) PG35HPBJK, UDI-DI: 10198956124110(each), 50198956124118(case), Lot Number: NGKU2052 ; 20) PG43MJEJD, UDI-DI: 10197106594261(each), 50197106594269(case), Lot Number: NGKW2883 ; 21) PG43MJEJD, UDI-DI: 10197106594261(each), 50197106594269(case), Lot Number: NGKW2883 ; 22) PVCGOTACF, UDI-DI: 10195594816469(each), 50195594816467(case), Lot Number: NGKV3487 ; 23) PVX4TAMYB, UDI-DI: 10197106892404(each), 50197106892402(case), Lot Number: NGKU4716 ; 24) PVX4TAMYB, UDI-DI: 10197106892404(each), 50197106892402(case), Lot Number: NGKU4716 ; 25) PVX4TAMYC, UDI-DI: 10198956329379(each), 50198956329377(case), Lot Number: NGKU4716 ; 26) PV23HEVAE, UDI-DI: 10198956062160(each), 50198956062168(case), Lot Number: NGKT2391 ; 27) PW35FABJE, UDI-DI: 10198956142282(each), 50198956142280(case), Lot Number: NGKT2394 ; 28) PW35FABJE, UDI-DI: 10198956142282(each), 50198956142280(case), Lot Number: NGKT2394 ; 29) PW35FABJE, UDI-DI: 10198956142282(each), 50198956142280(case), Lot Number: NGKT2394 ; 30) PW35FABJE, UDI-DI: 10198956142282(each), 50198956142280(case), Lot Number: NGKT2394 ; 31) SBA23RBHNG, UDI-DI: 10197106417577(each), 50197106417575(case), Lot Number: NGKU0129 ; 32) SBA23RBHNH, UDI-DI: 10198956332010(each), 50198956332018(case), Lot Number: NGKU0129

Devices named in this recall

20 devices in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 99553).

Sources and updates

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