Z-3098-2026Class II

Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, GVI OPEN HEART...

Name: Z-3098-2026 Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, GVI OPEN HEART...
Creator: Cardinal Health 200, LLC
Published: 2026-07-29
License: https://open.fda.gov/license/

Cardinal Health 200, LLC / initiated 2026-07-29 / Open, Classified / root cause: manufacturing process

FDA source

Cardinal Health 200, LLC began a recall of 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... on 2026-07-29. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3098-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-29
Posted: 2026-09-03
Recalling firm: Cardinal Health 200, LLC
Product: 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
Product code: OEZ Cardiovascular Procedure Kit
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.
Root cause tag: manufacturing process
FDA 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: [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.
Quantity in commerce: 2448 units
Distribution: US Nationwide distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3098-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3094-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-09-03
Z-3095-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-09-03
Z-3096-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-09-03
Z-3097-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-09-03
Z-3098-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-09-03
Z-3099-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-09-03
Z-3100-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-09-03
Z-3101-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-09-03
Z-3102-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-09-03
Z-3103-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-09-03
Z-3104-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-09-03
Z-3105-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-09-03

Product code OEZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-12. View this recall on fda.gov (opens on fda.gov)