Cardinal Health 200, LLC recalls Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:…
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, 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
Lot / code information
- UDI
- 10198956230057(each), 50198956230055(case)
- Lot #
- NGKT3319 ; 2) PCVNCG542
- UDI
- 10198956312463(each), 50198956312461(case)
- Lot #
- NGKU0951 ; 3) PCVNCG55I
- UDI
- 10197106283059(each), 50197106283057(case)
- Lot #
- NGKU0977 ; 4) PVCGBOB10
- UDI
- 10198956219885(each), 50198956219883(case)
- Lot #
- NGKT2391 ; 5) PVCGBOB11
- UDI
- 10198956220676(each), 50198956220674(case)
- Lot #
- NGKT2391 ; 6) PVCGBOB12
- UDI
- 10198956256477(each), 50198956256475(case)
- Lot #
- NGKT2391 ; 7) PVCGBOB17
- UDI
- 10198956393387(each), 50198956393385(case)
- Lot #
- NGKT2391 ; 8) PVCGOHCOH
- UDI
- 10198956022270(each), 50198956022278(case)
- Lot #
- NGKT2391 ; 9) PVCGOHCPA
- UDI
- 10197106666777(each), 50197106666775(case)
- Lot #
- NGKT3319 ; 10) PVCGOHCPA
- UDI
- 10197106666777(each), 50197106666775(case)
- Lot #
- NGKT3319 ; 11) PVCGOHCPA
- UDI
- 10197106666777(each), 50197106666775(case)
- Lot #
- NGKU0951 ; 12) PVHDCBAGK
- UDI
- 10197106946473(each), 50197106946471(case)
- Lot #
- NGKT2391 ; 13) PVHDCBAGK
- UDI
- 10197106946473(each), 50197106946471(case)
- Lot #
- NGKT2391 ; 14) PVHDCBAGK
- UDI
- 10197106946473(each), 50197106946471(case)
- Lot #
- NGKT2391 ; 15) PVHDCGVCP
- UDI
- 10198956254596(each), 50198956254594(case)
- Lot #
- NGKV2393 ; 16) PVHDCGVCP
- UDI
- 10198956254596(each), 50198956254594(case)
- Lot #
- NGKV2393 ; 17) PVHDCGVCP
- UDI
- 10198956254596(each), 50198956254594(case)
- Lot #
- NGKW2687 ; 18) PVHDCGVCP
- UDI
- 10198956254596(each), 50198956254594(case)
- Lot #
- NGKV2393 ; 19) PVHDCGVCP
- UDI
- 10198956254596(each), 50198956254594(case)
- Lot #
- NGKV2393 ; 20) PVHDCGV40
- UDI
- 10198956326941(each), 50198956326949(case)
- Lot #
- NGKV2393 ; 21) PVHDVAAGH
- UDI
- 10197106946459(each), 50197106946457(case)
- Lot #
- NGKT2391 ; 22) PVHDVPVCQ
- UDI
- 10198956254619(each), 50198956254617(case)
- Lot #
- NGKV2393 ; 23) PVHDVPVCQ
- UDI
- 10198956254619(each), 50198956254617(case)
- Lot #
- NGKV2393 ; 24) PVHDVPVCQ
- UDI
- 10198956254619(each), 50198956254617(case)
- Lot #
- NGKW2687 ; 25) PVHDVPVCQ
- UDI
- 10198956254619(each), 50198956254617(case)
- Lot #
- NGKW2687 ; 26) PVHDVPV43
- UDI
- 10198956354838(each), 50198956354836(case)
- Lot #
- NGKW2687 ; 27) PVOCMGJ36
- UDI
- 10198956248663(each), 50198956248661(case)
- Lot #
- NGKT2391 ; 28) PVOCOHNHE
- UDI
- 10198956071940(each), 50198956071948(case)
- Lot #
- NGKT2391 ; 29) PVOCOHNHE
- UDI
- 10198956071940(each), 50198956071948(case)
- Lot #
- NGKT2391 ; 30) PVOCOHNHE
- UDI
- 10198956071940(each), 50198956071948(case)
- Lot #
- NGKT2455 ; 31) PVOCOH12O
- UDI
- 10198956202054(each), 50198956202052(case)
- Lot #
- NGKT2391 ; 32) PVVMCV07E
- UDI
- 10198956179615(each), 50198956179613(case)
- Lot #
- NGKT2394 ; 33) PVVMFP22R
- UDI
- 10198956179653(each), 50198956179651(case)
- Lot #
- NGKT2394 ; 34) PVVMFP245
- UDI
- 10198956249141(each), 50198956249149(case)
- Lot #
- NGKT2394 ; 35) PVVMTH22J
- UDI
- 10198956119314(each), 50198956119312(case)
- Lot #
- NGKU0856 ; 36) PVVMTH22J
- UDI
- 10198956119314(each), 50198956119312(case)
- Lot #
- NGKU0957 ; 37) PVVMTH22J
- UDI
- 10198956119314(each), 50198956119312(case)
- Lot #
- NGKU0856 ; 38) PVVMTO22R
- UDI
- 10198956161016(each), 50198956161014(case)
- Lot #
- NGKT2394 ; 39) PVVMTO241
- UDI
- 10198956221741(each), 50198956221749(case)
- Lot #
- NGKT2394 ; 40) PVVMTO242
- UDI
- 10198956300521(each), 50198956300529(case)
- Lot #
- NGKT2394 ; 41) PVVXTHLCG
- UDI
- 10198956170759(each), 50198956170757(case)
- Lot #
- NGKT1789 ; 42) PVV2CC10R
- UDI
- 10198956285262(each), 50198956285260(case)
- Lot #
- NGKV3390 ; 43) PVV2CC10S
- UDI
- 10198956346611(each), 50198956346619(case)
- Lot #
- NGKV3390 ; 44) PVV2CC10S
- UDI
- 10198956346611(each), 50198956346619(case)
- Lot #
- NGKV2390 ; 45) PVV2MJ01M
- UDI
- 10198956285224(each), 50198956285222(case)
- Lot #
- NGKV3390 ; 46) PVV207962
- UDI
- 10198956212503(each), 50198956212501(case)
- Lot #
- NGKT2391 ; 47) PVV207963
- UDI
- 10198956244245(each), 50198956244243(case)
- Lot #
- NGKT2455 ; 48) PVV207964
- UDI
- 10198956255142(each), 50198956255140(case)
- Lot #
- NGKT2391 ; 49) PVV293340
- UDI
- 10198956218451(each), 50198956218459(case)
- Lot #
- NGKT2391 ; 50) PVV293362
- UDI
- 10198956240605(each), 50198956240603(case)
- Lot #
- NGKT2391 ; 51) PVV293363
- UDI
- 10198956248007(each), 50198956248005(case)
- Lot #
- NGKT2391 ; 52) PVX4CAP14
- UDI
- 10198956258921(each), 50198956258929(case)
- Lot #
- NGKU1994 ; 53) PVX4CRPR7
- UDI
- 10198956244894(each), 50198956244892(case)
- Lot #
- NGKU1994 ; 54) PVX4THEAA
- UDI
- 10197106795033(each), 50197106795031(case)
- Lot #
- NGKU4043 ; 55) PVX4THEAA
- UDI
- 10197106795033(each), 50197106795031(case)
- Lot #
- NGKU4716 ; 56) PV15CGSPF
- UDI
- 10197106847046(each), 50197106847044(case)
- Lot #
- NGKU0977 ; 57) PV15CGSPF
- UDI
- 10197106847046(each), 50197106847044(case)
- Lot #
- NGKU0951 ; 58) PV15CGSPG
- UDI
- 10198956324992(each), 50198956324990(case)
- Lot #
- NGKT3319 ; 59) PV15CGSPG
- UDI
- 10198956324992(each), 50198956324990(case)
- Lot #
- NGKU0951 ; 60) PV15MJSPD
- UDI
- 10197106847190(each), 50197106847198(case)
- Lot #
- NGKT3319 ; 61) PV15MJSPD
- UDI
- 10197106847190(each), 50197106847198(case)
- Lot #
- NGKU0977 ; 62) PV24OHN29
- UDI
- 10198956266315(each), 50198956266313(case)
- Lot #
- NGKU0977 ; 63) PV29OHMME
- UDI
- 10198956042827(each), 50198956042825(case)
- Lot #
- NGKT3319 ; 64) PV29OHMME
- UDI
- 10198956042827(each), 50198956042825(case)
- Lot #
- NGKU0977 ; 65) PV3LOHSGJ
- UDI
- 10198956127968(each), 50198956127966(case)
- Lot #
- NGKU1994 ; 66) PV33TCMYB
- UDI
- 10197106892442(each), 50197106892440(case)
- Lot #
- NGKU4716 ; 67) PV33TCMY3
- UDI
- 10198956263994(each), 50198956263992(case)
- Lot #
- NGKU2887 ; 68) PV40OHAR47
- UDI
- 10198956247086(each), 50198956247084(case)
- Lot #
- NGKT2391 ; 69) PV40OHAR48
- UDI
- 10198956249165(each), 50198956249163(case)
- Lot #
- NGKT2391 ; 70) PV40OHAR48
- UDI
- 10198956249165(each), 50198956249163(case)
- Lot #
- NGKT2455 ; 71) PV40OHAR49
- UDI
- 10198956257924(each), 50198956257922(case)
- Lot #
- NGKT2391 ; 72) PV40OHJUD
- UDI
- 10197106874844(each), 50197106874842(case)
- Lot #
- NGKT2455 ; 73) PV40OHJUD
- UDI
- 10197106874844(each), 50197106874842(case)
- Lot #
- NGKT2391 ; 74) PV40OHJUD
- UDI
- 10197106874844(each), 50197106874842(case)
- Lot #
- NGKT2455 ; 75) PV60OH15F
- UDI
- 10197106634905(each), 50197106634903(case)
- Lot #
- NGKT2391 ; 76) SCVCGPAACD
- UDI
- 10197106748169(each), 50197106748167(case)
- Lot #
- NGKU0977 ; 77) SCVCGPAACD
- UDI
- 10197106748169(each), 50197106748167(case)
- Lot #
- NGKU0951 ; 78) SCVCGPAACD
- UDI
- 10197106748169(each), 50197106748167(case)
- Lot #
- NGKT3319 ; 79) SCVCGTRACI
- UDI
- 10197106453735(each), 50197106453733(case)
- Lot #
- N/A ; 80) SCVCGVCG17
- UDI
- NGKU0957 (each), 10198956229624(case)
- Lot #
- 50198956229622; 81) SCVCGVCG18
- UDI
- NGKU0856 (each), 10198956230651(case)
- Lot #
- 50198956230659; 82) SCVCGVCS16
- UDI
- 10198956408548(each), 50198956408546(case)
- Lot #
- N/A ; 83) SCVCGVCS16
- UDI
- 10198956408548(each), 50198956408546(case)
- Lot #
- NGKV5078
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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 detailsHide
US Nationwide distribution.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-3098-2026
- FDA device classification · OEZOfficial FDA classification for this device type
- CFR regulation · 21 CFR 870.1200The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Cardinal Health 200, LLCSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
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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