FDA Device recall Z-3102-2026
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ROBOTIC HYST , Catalog Number: PB41RHRM3
- FDA Device
- Class II
- ongoing
- Published 2026-09-09
On 2026-09-09 the FDA classified a Class II recall of Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ROBOTIC HYST , Catalog Number: PB41RHRM3 by Cardinal Health 200, citing 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 i….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3102-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-29 |
| Published | 2026-09-09 |
| Last updated | 2026-09-15 05:30 UTC |
| Company | Cardinal Health 200 |
| Distribution | US |
Product
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ROBOTIC HYST , Catalog Number: PB41RHRM3; 2) KIT, ROBOTIC HYST , Catalog Number: PB41RHRM4; 3) KIT, C SECTION , Catalog Number: PLVMCS22G; 4) KIT, C SECTION MARTIN , Catalog Number: PL22CSMMI; 5) KIT, C SECTION MARTIN , Catalog Number: PL22CSMMI; 6) KIT, C SECTION OREGON HEALTH , Catalog Number: PL57CS60N; 7) C SECTION PACK , Catalog Number: SMAHBCSECB; 8) C SECTION PACK , Catalog Number: SMAHBCSEC3
Reason
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.
Identifiers
| code_info | 1) PB41RHRM3, UDI-DI: 10198956294219(each), 50198956294217(case), Lot Number: NGKU3049 ; 2) PB41RH…1) PB41RHRM3, UDI-DI: 10198956294219(each), 50198956294217(case), Lot Number: NGKU3049 ; 2) PB41RHRM3, UDI-DI: 10198956294219(each), 50198956294217(case), Lot Number: NGKU4043 ; 3) PB41RHRM4, UDI-DI: 10197106968413(each), 50197106968411(case), Lot Number: NGKU4716 ; 4) PLVMCS22G, UDI-DI: 10198956198890(each), 50198956198898(case), Lot Number: NGKU0957 ; 5) PLVMCS22G, UDI-DI: 10198956198890(each), 50198956198898(case), Lot Number: NGKU0856 ; 6) PLVMCS22G, UDI-DI: 10198956198890(each), 50198956198898(case), Lot Number: NGKU0957 ; 7) PLVMCS22G, UDI-DI: 10198956198890(each), 50198956198898(case), Lot Number: NGKU2052 ; 8) PLVMCS22G, UDI-DI: 10198956198890(each), 50198956198898(case), Lot Number: NGKU2052 ; 9) PL22CSMMI, UDI-DI: 10195594952600(each), 50195594952608(case), Lot Number: NGKU0129 ; 10) PL22CS |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-15 05:30 UTC. Current status: ongoing.
Other recalls by Cardinal Health 200
- Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT,GU DAVINCI , Catalog Number: PGVMDVBWU
FDA Device · Class II · 2026-10-07 · Cardinal Health 200 - Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLAC
FDA Device · Class II · 2026-10-07 · Cardinal Health 200 - Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAP CHOLE , Catalog Number: PGCGLCBAC
FDA Device · Class II · 2026-10-07 · Cardinal Health 200 - Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAVH , Catalog Number: PB63VHSTC
FDA Device · Class II · 2026-10-07 · Cardinal Health 200 - Presource Convenience Kits: 1) KIT, PRE OP , Catalog Number: AMN548616A
FDA Device · Class II · 2026-09-30 · Cardinal Health 200
All Cardinal Health 200 recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3102-2026%22
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