Recall Z-3095-2026
- Recall number
- Z-3095-2026
- Event number
- 99553
- Firm
- Cardinal Health 200, LLC
- Firm FEI
- 3001236905
- Product code
- LRO
- Status
- Open, Classified
- Initiated
- 2026-07-29
- Posted
- 2026-09-03
- Root cause
- Process change control
- 510(k) numbers
- K970187, K871434, K890570, K902887, K935741, K935740, K023276, K931758, K980137, K950574, K945831, K872448, K890726, K872011, K914037, K914036, K920267, K932221, K924468, K895202, K931760, K951149, K961863, K920292, K854292, K934428, K874439, K910365, K963443, K913136
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.