FDA Medical devices recall ·
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary… recall
- Recall number
- Z-3101-2026
- Date
- (initiated July 29, 2026)
- Company / brand
- Cardinal Health 200, LLC
3651 Birchwood Dr, Waukegan, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1398 units
- Hazard tags
- Microbial contamination
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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(cas
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-3101-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.