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Presource Packs Containing CliniClean Pericare Wipes within… recallZ-3098-2026 · 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-3098-2026
Status
Open, Classified
Initiated by the company
Jul 29, 2026
Posted by the FDA
Sep 3, 2026
Recalling firm
Cardinal Health 200, LLC
Quantity
2448 units
Product code
OEZ
Distribution
US Nationwide distribution.

Product description

Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, GVI OPEN HEART A B , Catalog Number: PCVNCG540; 2) KIT, GVI OPEN HEART A B , Catalog Number: PCVNCG542; 3) KIT, GVI OPEN HEART A B , Catalog Number: PCVNCG55I; 4) KIT, BLO BASIC OPEN HEART , Catalog Number: PVCGBOB10; 5) KIT, BLO BASIC OPEN HEART , Catalog Number: PVCGBOB10; 6) KIT, BLO BASIC OPEN HEART , Catalog Number: PVCGBOB12; 7) KIT, BLO BASIC OPEN HEART , Catalog Number: PVCGBOB17; 8) KIT, OPEN HEART CON , Catalog Number: PVCGOHCOH; 9) KIT,OPEN HEART ADULT MDST , Catalog Number: PVCGOHCPA; 10) KIT, CABG , Catalog Number: PVHDCBAGK; 11) KIT, ORP CABG , Catalog Number: PVHDCGVCP; 12) KIT, ORP CABG , Catalog Number: PVHDCGV40; 13) KIT, VALVE , Catalog Number: PVHDVAAGH; 14) KIT, ORP VALVE , Catalog Number: PVHDVPVCQ; 15) KIT, ORP VALVE , Catalog Number: PVHDVPV43; 16) KIT, MAJOR CARDIAC , Catalog Number: PVOCMGJ36; 17) KIT, OPEN HEART DH , Catalog Number: PVOCOHNHE; 18) KIT, OPEN HEART , Catalog Number: PVOCOH12O; 19) KIT, CAROTID ENDARTERECTOMY , Catalog Number: PVVMCV07E; 20) KIT, FEM POP BARNES JEW , Catalog Number: PVVMFP22R; 21) KIT, FEM POP BARNES JEW , Catalog Number: PVVMFP245; 22) KIT, THORACIC BARNES JEWISH , Catalog Number: PVVMTH22J; 23) KIT, THORACIC OUTLET SYNDROME , Catalog Number: PVVMTO22R; 24) KIT, THORACIC OUTLET SYNDROME , Catalog Number: PVVMTO241; 25) KIT, THORACIC OUTLET SYNDROME , Catalog Number: PVVMTO242; 26) KIT, THORACIC , Catalog Number: PVVXTHLCG; 27) KIT,OPEN HEART BASIC PRESBYTER, Catalog Number: PVV2CC10R; 28) KIT,OPEN HEART BASIC PRESBYTER, Catalog Number: PVV2CC10S; 29) KIT, MAJOR VASC, PRESBYTERIAN , Catalog Number: PVV2MJ01M; 30) KIT, CARDIAC VALVE , Catalog Number: PVV207962; 31) KIT, CARDIAC VALVE , Catalog Number: PVV207963; 32) KIT, CARDIAC VALVE , Catalog Number: PVV207964; 33) KIT, CARDIAC CABG , Catalog Number: PVV293340; 34) KIT, CARDIAC CABG , Catalog Number: PVV293362; 35) KIT, CARDIAC CABG , Catalog Number: PVV293363; 36) KIT, PUH CARDIAC CABG , Catalog Number: PVX4CAP14; 37) KIT, PUH CARDIAC , Catalog Number: PVX4CRPR7; 38) KIT, EAS THORACIC ABDOMINAL , Catalog Number: PVX4THEAA; 39) KIT, CV , Catalog Number: PV15CGSPF; 40) KIT, CV , Catalog Number: PV15CGSPG; 41) KIT,MAJOR VASCULAR , Catalog Number: PV15MJSPD; 42) KIT, OPEN HEART SET UP , Catalog Number: PV24OHN29; 43) KIT, OPEN HEART , Catalog Number: PV29OHMME; 44) KIT, OPEN HEART , Catalog Number: PV3LOHSGJ; 45) KIT, MER THORACOTOMY CHEST , Catalog Number: PV33TCMYB; 46) KIT, MER THORACOTOMY CHEST , Catalog Number: PV33TCMY3; 47) KIT, BASIC OPEN HEART , Catalog Number: PV40OHAR47; 48) KIT, BASIC OPEN HEART , Catalog Number: PV40OHAR48; 49) KIT, BASIC OPEN HEART , Catalog Number: PV40OHAR49; 50) KIT, OPEN HEART , Catalog Number: PV40OHJUD; 51) KIT, MODULE OPEN HEART , Catalog Number: PV60OH15F; 52) CV W AUX PACK 2 OF 2 CMC , Catalog Number: SCVCGPAACD; 53) THORACIC ROBOTIC PACK CMC , Catalog Number: SCVCGTRACI; 54) CV PACK 2 OF 2 GSH , Catalog Number: SCVCGVCG17; 55) CV PACK 2 OF 2 GSH , Catalog Number: SCVCGVCG18; 56) CV PACK 2 OF 2 SHER , Catalog Number: SCVCGVCS16

Code information (models, lots, serial numbers)

Show the full code information (9k characters)

1) PCVNCG540, UDI-DI: 10198956230057(each), 50198956230055(case), Lot Number: NGKT3319 ; 2) PCVNCG542, UDI-DI: 10198956312463(each), 50198956312461(case), Lot Number: NGKU0951 ; 3) PCVNCG55I, UDI-DI: 10197106283059(each), 50197106283057(case), Lot Number: NGKU0977 ; 4) PVCGBOB10, UDI-DI: 10198956219885(each), 50198956219883(case), Lot Number: NGKT2391 ; 5) PVCGBOB11, UDI-DI: 10198956220676(each), 50198956220674(case), Lot Number: NGKT2391 ; 6) PVCGBOB12, UDI-DI: 10198956256477(each), 50198956256475(case), Lot Number: NGKT2391 ; 7) PVCGBOB17, UDI-DI: 10198956393387(each), 50198956393385(case), Lot Number: NGKT2391 ; 8) PVCGOHCOH, UDI-DI: 10198956022270(each), 50198956022278(case), Lot Number: NGKT2391 ; 9) PVCGOHCPA, UDI-DI: 10197106666777(each), 50197106666775(case), Lot Number: NGKT3319 ; 10) PVCGOHCPA, UDI-DI: 10197106666777(each), 50197106666775(case), Lot Number: NGKT3319 ; 11) PVCGOHCPA, UDI-DI: 10197106666777(each), 50197106666775(case), Lot Number: NGKU0951 ; 12) PVHDCBAGK, UDI-DI: 10197106946473(each), 50197106946471(case), Lot Number: NGKT2391 ; 13) PVHDCBAGK, UDI-DI: 10197106946473(each), 50197106946471(case), Lot Number: NGKT2391 ; 14) PVHDCBAGK, UDI-DI: 10197106946473(each), 50197106946471(case), Lot Number: NGKT2391 ; 15) PVHDCGVCP, UDI-DI: 10198956254596(each), 50198956254594(case), Lot Number: NGKV2393 ; 16) PVHDCGVCP, UDI-DI: 10198956254596(each), 50198956254594(case), Lot Number: NGKV2393 ; 17) PVHDCGVCP, UDI-DI: 10198956254596(each), 50198956254594(case), Lot Number: NGKW2687 ; 18) PVHDCGVCP, UDI-DI: 10198956254596(each), 50198956254594(case), Lot Number: NGKV2393 ; 19) PVHDCGVCP, UDI-DI: 10198956254596(each), 50198956254594(case), Lot Number: NGKV2393 ; 20) PVHDCGV40, UDI-DI: 10198956326941(each), 50198956326949(case), Lot Number: NGKV2393 ; 21) PVHDVAAGH, UDI-DI: 10197106946459(each), 50197106946457(case), Lot Number: NGKT2391 ; 22) PVHDVPVCQ, UDI-DI: 10198956254619(each), 50198956254617(case), Lot Number: NGKV2393 ; 23) PVHDVPVCQ, UDI-DI: 10198956254619(each), 50198956254617(case), Lot Number: NGKV2393 ; 24) PVHDVPVCQ, UDI-DI: 10198956254619(each), 50198956254617(case), Lot Number: NGKW2687 ; 25) PVHDVPVCQ, UDI-DI: 10198956254619(each), 50198956254617(case), Lot Number: NGKW2687 ; 26) PVHDVPV43, UDI-DI: 10198956354838(each), 50198956354836(case), Lot Number: NGKW2687 ; 27) PVOCMGJ36, UDI-DI: 10198956248663(each), 50198956248661(case), Lot Number: NGKT2391 ; 28) PVOCOHNHE, UDI-DI: 10198956071940(each), 50198956071948(case), Lot Number: NGKT2391 ; 29) PVOCOHNHE, UDI-DI: 10198956071940(each), 50198956071948(case), Lot Number: NGKT2391 ; 30) PVOCOHNHE, UDI-DI: 10198956071940(each), 50198956071948(case), Lot Number: NGKT2455 ; 31) PVOCOH12O, UDI-DI: 10198956202054(each), 50198956202052(case), Lot Number: NGKT2391 ; 32) PVVMCV07E, UDI-DI: 10198956179615(each), 50198956179613(case), Lot Number: NGKT2394 ; 33) PVVMFP22R, UDI-DI: 10198956179653(each), 50198956179651(case), Lot Number: NGKT2394 ; 34) PVVMFP245, UDI-DI: 10198956249141(each), 50198956249149(case), Lot Number: NGKT2394 ; 35) PVVMTH22J, UDI-DI: 10198956119314(each), 50198956119312(case), Lot Number: NGKU0856 ; 36) PVVMTH22J, UDI-DI: 10198956119314(each), 50198956119312(case), Lot Number: NGKU0957 ; 37) PVVMTH22J, UDI-DI: 10198956119314(each), 50198956119312(case), Lot Number: NGKU0856 ; 38) PVVMTO22R, UDI-DI: 10198956161016(each), 50198956161014(case), Lot Number: NGKT2394 ; 39) PVVMTO241, UDI-DI: 10198956221741(each), 50198956221749(case), Lot Number: NGKT2394 ; 40) PVVMTO242, UDI-DI: 10198956300521(each), 50198956300529(case), Lot Number: NGKT2394 ; 41) PVVXTHLCG, UDI-DI: 10198956170759(each), 50198956170757(case), Lot Number: NGKT1789 ; 42) PVV2CC10R, UDI-DI: 10198956285262(each), 50198956285260(case), Lot Number: NGKV3390 ; 43) PVV2CC10S, UDI-DI: 10198956346611(each), 50198956346619(case), Lot Number: NGKV3390 ; 44) PVV2CC10S, UDI-DI: 10198956346611(each), 50198956346619(case), Lot Number: NGKV2390 ; 45) PVV2MJ01M, UDI-DI: 10198956285224(each), 50198956285222(case), Lot Number: NGKV3390 ; 46) PVV207962, UDI-DI: 10198956212503(each), 50198956212501(case), Lot Number: NGKT2391 ; 47) PVV207963, UDI-DI: 10198956244245(each), 50198956244243(case), Lot Number: NGKT2455 ; 48) PVV207964, UDI-DI: 10198956255142(each), 50198956255140(case), Lot Number: NGKT2391 ; 49) PVV293340, UDI-DI: 10198956218451(each), 50198956218459(case), Lot Number: NGKT2391 ; 50) PVV293362, UDI-DI: 10198956240605(each), 50198956240603(case), Lot Number: NGKT2391 ; 51) PVV293363, UDI-DI: 10198956248007(each), 50198956248005(case), Lot Number: NGKT2391 ; 52) PVX4CAP14, UDI-DI: 10198956258921(each), 50198956258929(case), Lot Number: NGKU1994 ; 53) PVX4CRPR7, UDI-DI: 10198956244894(each), 50198956244892(case), Lot Number: NGKU1994 ; 54) PVX4THEAA, UDI-DI: 10197106795033(each), 50197106795031(case), Lot Number: NGKU4043 ; 55) PVX4THEAA, UDI-DI: 10197106795033(each), 50197106795031(case), Lot Number: NGKU4716 ; 56) PV15CGSPF, UDI-DI: 10197106847046(each), 50197106847044(case), Lot Number: NGKU0977 ; 57) PV15CGSPF, UDI-DI: 10197106847046(each), 50197106847044(case), Lot Number: NGKU0951 ; 58) PV15CGSPG, UDI-DI: 10198956324992(each), 50198956324990(case), Lot Number: NGKT3319 ; 59) PV15CGSPG, UDI-DI: 10198956324992(each), 50198956324990(case), Lot Number: NGKU0951 ; 60) PV15MJSPD, UDI-DI: 10197106847190(each), 50197106847198(case), Lot Number: NGKT3319 ; 61) PV15MJSPD, UDI-DI: 10197106847190(each), 50197106847198(case), Lot Number: NGKU0977 ; 62) PV24OHN29, UDI-DI: 10198956266315(each), 50198956266313(case), Lot Number: NGKU0977 ; 63) PV29OHMME, UDI-DI: 10198956042827(each), 50198956042825(case), Lot Number: NGKT3319 ; 64) PV29OHMME, UDI-DI: 10198956042827(each), 50198956042825(case), Lot Number: NGKU0977 ; 65) PV3LOHSGJ, UDI-DI: 10198956127968(each), 50198956127966(case), Lot Number: NGKU1994 ; 66) PV33TCMYB, UDI-DI: 10197106892442(each), 50197106892440(case), Lot Number: NGKU4716 ; 67) PV33TCMY3, UDI-DI: 10198956263994(each), 50198956263992(case), Lot Number: NGKU2887 ; 68) PV40OHAR47, UDI-DI: 10198956247086(each), 50198956247084(case), Lot Number: NGKT2391 ; 69) PV40OHAR48, UDI-DI: 10198956249165(each), 50198956249163(case), Lot Number: NGKT2391 ; 70) PV40OHAR48, UDI-DI: 10198956249165(each), 50198956249163(case), Lot Number: NGKT2455 ; 71) PV40OHAR49, UDI-DI: 10198956257924(each), 50198956257922(case), Lot Number: NGKT2391 ; 72) PV40OHJUD, UDI-DI: 10197106874844(each), 50197106874842(case), Lot Number: NGKT2455 ; 73) PV40OHJUD, UDI-DI: 10197106874844(each), 50197106874842(case), Lot Number: NGKT2391 ; 74) PV40OHJUD, UDI-DI: 10197106874844(each), 50197106874842(case), Lot Number: NGKT2455 ; 75) PV60OH15F, UDI-DI: 10197106634905(each), 50197106634903(case), Lot Number: NGKT2391 ; 76) SCVCGPAACD, UDI-DI: 10197106748169(each), 50197106748167(case), Lot Number: NGKU0977 ; 77) SCVCGPAACD, UDI-DI: 10197106748169(each), 50197106748167(case), Lot Number: NGKU0951 ; 78) SCVCGPAACD, UDI-DI: 10197106748169(each), 50197106748167(case), Lot Number: NGKT3319 ; 79) SCVCGTRACI, UDI-DI: 10197106453735(each), 50197106453733(case), Lot Number: N/A ; 80) SCVCGVCG17, UDI-DI: NGKU0957 (each), 10198956229624(case), Lot Number: 50198956229622; 81) SCVCGVCG18, UDI-DI: NGKU0856 (each), 10198956230651(case), Lot Number: 50198956230659; 82) SCVCGVCS16, UDI-DI: 10198956408548(each), 50198956408546(case), Lot Number: N/A ; 83) SCVCGVCS16, UDI-DI: 10198956408548(each), 50198956408546(case), Lot Number: NGKV5078

Devices named in this recall

56 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

How recalls are matched to devices · Editorial policy · Report an error on this page