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RecallWatchMedical Device Safety
Class IIOngoingZ-3095-2026

Cardinal Health 200, LLC recalls Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:…

Cardinal Health 200, LLCWaukegan, IL, United StatesReported Sep 9, 2026 · 6 days ago
Legal News Analyst ·

Reason for recall

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

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

Lot / code information

UDI
10197106840085(each), 50197106840083(case)
Lot #
NGKU0957 ; 2) PB35GYBJC
UDI
10197106375723(each), 50197106375721(case)
Lot #
NGKU2052 ; 3) PGVMOTBB19
UDI
10198956264113(each), 50198956264111(case)
Lot #
NGKT2394 ; 4) PGVM07C26
UDI
10198956264434(each), 50198956264432(case)
Lot #
NGKT2394 ; 5) PGVM07C27
UDI
10198956292895(each), 50198956292893(case)
Lot #
NGKT2394 ; 6) PGV2LTNHN
Show 54 more code fields
UDI
10198956292499(each), 50198956292497(case)
Lot #
NGKV2390 ; 7) PGV2LTNHN
UDI
10198956292499(each), 50198956292497(case)
Lot #
NGKV3390 ; 8) PG15OT92A
UDI
10197106475041(each), 50197106475049(case)
Lot #
NGKW2883 ; 9) PG23MLNLD
UDI
10198956432024(each), 50198956432022(case)
Lot #
NGKU3969 ; 10) PG29GCPCK
UDI
10198956299207(each), 50198956299205(case)
Lot #
NGKU4716 ; 11) PG29GCPC3
UDI
10198956532496(each), 50198956532494(case)
Lot #
NGKU4716 ; 12) PG33LVMNC
UDI
10198956188358(each), 50198956188356(case)
Lot #
NGKU1994 ; 13) PG33LVMNC
UDI
10198956188358(each), 50198956188356(case)
Lot #
NGKU1994 ; 14) PG33LVMNC
UDI
10198956188358(each), 50198956188356(case)
Lot #
NGKU1994 ; 15) PG33LVMNC
UDI
10198956188358(each), 50198956188356(case)
Lot #
NGKU1994 ; 16) PG35HPBJK
UDI
10198956124110(each), 50198956124118(case)
Lot #
NGKU0856 ; 17) PG35HPBJK
UDI
10198956124110(each), 50198956124118(case)
Lot #
NGKU0957 ; 18) PG35HPBJK
UDI
10198956124110(each), 50198956124118(case)
Lot #
NGKU0957 ; 19) PG35HPBJK
UDI
10198956124110(each), 50198956124118(case)
Lot #
NGKU2052 ; 20) PG43MJEJD
UDI
10197106594261(each), 50197106594269(case)
Lot #
NGKW2883 ; 21) PG43MJEJD
UDI
10197106594261(each), 50197106594269(case)
Lot #
NGKW2883 ; 22) PVCGOTACF
UDI
10195594816469(each), 50195594816467(case)
Lot #
NGKV3487 ; 23) PVX4TAMYB
UDI
10197106892404(each), 50197106892402(case)
Lot #
NGKU4716 ; 24) PVX4TAMYB
UDI
10197106892404(each), 50197106892402(case)
Lot #
NGKU4716 ; 25) PVX4TAMYC
UDI
10198956329379(each), 50198956329377(case)
Lot #
NGKU4716 ; 26) PV23HEVAE
UDI
10198956062160(each), 50198956062168(case)
Lot #
NGKT2391 ; 27) PW35FABJE
UDI
10198956142282(each), 50198956142280(case)
Lot #
NGKT2394 ; 28) PW35FABJE
UDI
10198956142282(each), 50198956142280(case)
Lot #
NGKT2394 ; 29) PW35FABJE
UDI
10198956142282(each), 50198956142280(case)
Lot #
NGKT2394 ; 30) PW35FABJE
UDI
10198956142282(each), 50198956142280(case)
Lot #
NGKT2394 ; 31) SBA23RBHNG
UDI
10197106417577(each), 50197106417575(case)
Lot #
NGKU0129 ; 32) SBA23RBHNH
UDI
10198956332010(each), 50198956332018(case)
Lot #
NGKU0129

What the firm 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: 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.

DistributionShow details

US Nationwide distribution.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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