Z-3101-2026 Class II Ongoing
FDA device recall Z-3101-2026 was initiated by Cardinal Health 200, LLC on July 29, 2026 and is designated Class II. 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, … The recall status is ongoing. Affected quantity: 1398 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 9, 2026
- Initiation Date
- July 29, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1398 units
Product Description
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.
Distribution Pattern
US Nationwide distribution.
Code Information
1) PBCGRGB28, UDI-DI: 10198956432567(each), 50198956432565(case), Lot Number: GKU1823 ; 2) PBVMLP22G, UDI-DI: 10198956123854(each), 50198956123852(case), Lot Number: NGKU2052 ; 3) PBVM0722D, UDI-DI: 10198956124134(each), 50198956124132(case), Lot Number: NGKU0856 ; 4) PBVM0722D, UDI-DI: 10198956124134(each), 50198956124132(case), Lot Number: NGKU0957 ; 5) PBVM0722D, UDI-DI: 10198956124134(each), 50198956124132(case), Lot Number: NGKU0856 ; 6) PBVM0722D, UDI-DI: 10198956124134(each), 50198956124132(case), Lot Number: NGKU0957 ; 7) PBV2MJMVH, UDI-DI: 10198956285248(each), 50198956285246(case), Lot Number: NGKV3390 ; 8) PB13GYAJD, UDI-DI: 10198956125193(each), 50198956125191(case), Lot Number: NGKV3390 ; 9) PB43LSEJG, UDI-DI: 10198956200999(each), 50198956200997(case), Lot Number: NGKW2883 ; 10) SMACGGRACE, UDI-DI: 10197106820506(each), 50197106820504(case), Lot Number: NGKU0856 ; 11) SMACGGRACE, UDI-DI: 10197106820506(each), 50197106820504(case), Lot Number: NGKU2052 ; 12) SMAOCGYLHL, UDI-DI: 10198956257214(each), 50198956257212(case), Lot Number: NGKW0682 ; 13) SMAOCGYLHL, UDI-DI: 10198956257214(each), 50198956257212(case), Lot Number: NGKW3769 ; 14) SMAOCGYLHL, UDI-DI: 10198956257214(each), 50198956257212(case), Lot Number: NGKW3769 ; 15) SMAOCGYLHL, UDI-DI: 10198956257214(each), 50198956257212(case), Lot Number: NGKW3769 ; 16) SMAVPDWTMC, UDI-DI: 10197106678053(each), 50197106678051(case), Lot Number: GKU1823 ; 17) SMAVPDWTMC, UDI-DI: 10197106678053(each), 50197106678051(case), Lot Number: GKU1823 ; 18) SMA4JGRODB, UDI-DI: 10197106670545(each), 50197106670543(case), Lot Number: NGKU0129 ; 19) SMA4JGRODB, UDI-DI: 10197106670545(each), 50197106670543(case), Lot Number: NGKU0129 ; 20) SMA4JLGODA, UDI-DI: 10197106674949(each), 50197106674947(case), Lot Number: NGKU0129 ; 21) SMA4JLGODA, UDI-DI: 10197106674949(each), 50197106674947(case), Lot Number: NGKU0129