FDA Device recall Z-3097-2026
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,ROBOTICS DH , Catalog Number: PGOCRDNHD
- 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,ROBOTICS DH , Catalog Number: PGOCRDNHD 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-3097-2026 |
| 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,ROBOTICS DH , Catalog Number: PGOCRDNHD; 2) KIT, EAS ROBOTIC , Catalog Number: PG36RPEAB; 3) KIT, VIDEO THORACOSCOPY CMC , Catalog Number: PVCGVTACF
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) PGOCRDNHD, UDI-DI: 10198956057012(each), 50198956057010(case), Lot Number: NGKV3390 ; 2) PG36RP…1) PGOCRDNHD, UDI-DI: 10198956057012(each), 50198956057010(case), Lot Number: NGKV3390 ; 2) PG36RPEAB, UDI-DI: 10198956225091(each), 50198956225099(case), Lot Number: NGKU2052 ; 3) PVCGVTACF, UDI-DI: 10195594816568(each), 50195594816566(case), Lot Number: NGKV3487 ; 4) PVCGVTACF, UDI-DI: 10195594816568(each), 50195594816566(case), Lot Number: NGKV3487 |
|---|
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-3097-2026%22
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