Presource Packs Containing CliniClean Pericare Wipes within BD… — Class II medical device recall Z-3098-2026
Ongoing recall by Cardinal Health 200, LLC, reported 2026-09-09, distributed nationwide. The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubr
| Recall number | Z-3098-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health 200, LLC, Waukegan, IL, United States |
| Recall initiated | 2026-07-29 |
| Classified | 2026-09-03 |
| Reported by FDA | 2026-09-09 |
| Distributed | Nationwide (US) |
| Quantity | 2,448 units |
| UPC / GTIN / UDI-DI | 10197106283059, 10197106453735, 10197106634905, 10197106666777, 10197106748169, 10197106795033, 10197106847046, 10197106847190, 10197106874844, 10197106892442, 10197106946459, 10197106946473, 10198956022270, 10198956042827, 10198956071940, 10198956119314, 10198956127968, 10198956161016, 10198956170759, 10198956179615, 10198956179653, 10198956202054, 10198956212503, 10198956218451, 10198956219885 and 87 more |
| Lot numbers | NGKT1789, NGKT2391, NGKT2394, NGKT2455, NGKT3319, NGKU0856, NGKU0951, NGKU0957, NGKU0977, NGKU1994, NGKU2887, NGKU4043, NGKU4716, NGKV2390, NGKV2393, NGKV3390, NGKV5078, NGKW2687 |
| Model numbers | PCVNCG540, PCVNCG542, PCVNCG55I, PV15CGSPF, PV15CGSPG, PV15MJSPD, PV24OHN29, PV29OHMME, PV33TCMY3, PV33TCMYB, PV3LOHSGJ, PV40OHAR47, PV40OHAR48, PV40OHAR49, PV40OHJUD, PV60OH15F, PVCGBOB10, PVCGBOB12, PVCGBOB17, PVHDCGV40, PVHDVPV43, PVOCMGJ36, PVOCOH12O, PVV207962, PVV207963 and 20 more |
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3098-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.