Recall Z-3101-2026
Cardinal Health 200, LLC · initiated July 29, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: 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:…
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.
FDA-determined cause: Process change control
Action taken
An URGENT: PRODUCT CORRECTION notification letter dated 7/29/26 was sent to customers. If you locate affected product within your facility, please do the following: 1. QUARANTINE affected kits. 2. ALERT your clinicians of this action. 3. AFFIX a WARNING LABEL to the front of each Presource kit so that it is clearly visible to clinicians, instructing them to remove and discard the recalled component(s). 4. RETURN a copy of the enclosed Acknowledgment Form confirming your receipt of this action and the completion of labeling product via fax to 614.652.9648. Additional labels will be sent to your facility upon request. Please send an email to: gmb-FieldCorrectiveAction@cardinalhealth.com For component credit or replacement, please contact the following: " Hospitals Cardinal Customer Service at 866.551.0533 " Distributors Distributor Management at 800.635.6021 " Federal Government facilities Government Customer Service at 800.444.1166 If you are a Distributor and have further distributed affected kits please notify your customers of this recall. We sincerely apologize for any inconvenience this notice may have caused you and your staff. Should you have any questions, require additional labels or desire special assistance relating to this recall, please feel free to contact Cardinal Health Quality Systems at 800.292.9332.
Details
- Recall number
- Z-3101-2026
- Initiated
- July 29, 2026
- Posted by FDA
- September 3, 2026
- Product code
- OHD – Gynecological Laparoscopic Kit
- Quantity
- 1398 units
- Distribution
- US Nationwide distribution.
- Recalling firm
- Cardinal Health 200, LLC, Waukegan, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-3094-2026 Class II | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:…The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a… | 07/29/2026Open, Classified |
| Z-3095-2026 Class II | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:…The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a… | 07/29/2026Open, Classified |
| Z-3096-2026 Class II | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:…The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a… | 07/29/2026Open, Classified |
| Z-3097-2026 Class II | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:…The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a… | 07/29/2026Open, Classified |
| Z-3098-2026 Class II | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:…The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a… | 07/29/2026Open, Classified |
| Z-3099-2026 Class II | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:…The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a… | 07/29/2026Open, Classified |
| Z-3100-2026 Class II | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:…The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a… | 07/29/2026Open, Classified |
| Z-3102-2026 Class II | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:…The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a… | 07/29/2026Open, Classified |
| Z-3103-2026 Class II | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:…The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a… | 07/29/2026Open, Classified |
| Z-3104-2026 Class II | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:…The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a… | 07/29/2026Open, Classified |
| Z-3105-2026 Class II | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:…The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a… | 07/29/2026Open, Classified |