Cardinal Health 200, LLC: 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

Recall number

Z-3095-2026

Recalling firm

Cardinal Health 200, LLC

Product

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

Status

Open, Classified

Initiated

2026-07-29

Posted

2026-09-03

Terminated

not on file

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.

Root cause

Process change control

Action

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: gmb-FieldCorrectiveAction@cardinalhealth.com 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.

Quantity

846 units

Distribution

US Nationwide distribution.

Lot, serial or model codes

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

510(k) numbers

not on file

PMA numbers

not on file

Product code

LRO

Firm FEI

3001236905

Firm city

Waukegan

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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