Presource Packs Containing CliniClean Pericare Wipes within BD… — Class II medical device recall Z-3095-2026
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-3095-2026 |
|---|---|
| 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 | 846 units |
| UPC / GTIN / UDI-DI | 10195594816469, 10197106375723, 10197106417577, 10197106475041, 10197106594261, 10197106840085, 10197106892404, 10198956062160, 10198956124110, 10198956142282, 10198956188358, 10198956264113, 10198956264434, 10198956292499, 10198956292895, 10198956299207, 10198956329379, 10198956332010, 10198956432024, 10198956532496, 50195594816467, 50197106375721, 50197106417575, 50197106475049, 50197106594269 and 15 more |
| Lot numbers | NGKT2391, NGKT2394, NGKU0129, NGKU0856, NGKU0957, NGKU1994, NGKU2052, NGKU3969, NGKU4716, NGKV2390, NGKV3390, NGKV3487, NGKW2883 |
| Model numbers | PB35GYBJC, PG15OT92A, PG23MLNLD, PG29GCPC3, PG29GCPCK, PG33LVMNC, PG35HPBJK, PG43MJEJD, PGV2LTNHN, PGVM07C26, PGVMOTBB19, PV23HEVAE, PVX4TAMYB, PVX4TAMYC, PW35FABJE, SBA23RBHNG, SBA23RBHNH |
Product
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
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-3095-2026. 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.