Presource Packs Containing CliniClean Pericare Wipes within BD… — Class II medical device recall Z-3101-2026
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-3101-2026 |
|---|---|
| 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 | 1,398 units |
| UPC / GTIN / UDI-DI | 10197106670545, 10197106674949, 10197106678053, 10197106820506, 10198956123854, 10198956124134, 10198956125193, 10198956200999, 10198956257214, 10198956285248, 10198956432567, 50197106670543, 50197106674947, 50197106678051, 50197106820504, 50198956123852, 50198956124132, 50198956125191, 50198956200997, 50198956257212, 50198956285246, 50198956432565 |
| Lot numbers | GKU1823, NGKU0129, NGKU0856, NGKU0957, NGKU2052, NGKV3390, NGKW0682, NGKW2883, NGKW3769 |
| Model numbers | PB43LSEJG, PBCGRGB28, PBV2MJMVH, PBVM0722D, PBVMLP22G, SMA4JGRODB, SMA4JLGODA |
Product
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, BLO ROBOTIC GYN , Catalog Number: PBCGRGB28; 2) KIT , GYN MAJOR BARNES JEWIS, Catalog Number: PBVMLP22G; 3) KIT, GYN OPERATIVE LAPAROSCOPY, Catalog Number: PBVM0722D; 4) KIT,MAJOR VAGINAL,PRESBYTERIAN, Catalog Number: PBV2MJMVH; 5) KIT, GYN LAPAROSCOPY , Catalog Number: PBV2MJMVH; 6) KIT, GYN LAPAROSCOPY , Catalog Number: PB43LSEJG; 7) GYNE ROBOTIC PACK CMC , Catalog Number: SMACGGRACE; 8) LH GYN ROBOTICS PK , Catalog Number: SMAOCGYLHL; 9) DAVINCI PACK WOMENS , Catalog Number: SMAVPDWTMC; 10) PK GYN ROBOTICS OD , Catalog Number: SMA4JGRODB; 11) PK LAPAROSCOPY GYN OD , Catalog Number: SMA4JLGODA
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-3101-2026. 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.