Procedure packs: — Class II medical device recall Z-0086-2024
Ongoing recall by Cardinal Health 200, LLC, reported 2023-10-18, distributed nationwide. Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).
| Recall number | Z-0086-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health 200, LLC, Waukegan, IL, United States |
| Recall initiated | 2023-08-16 |
| Classified | 2023-10-10 |
| Reported by FDA | 2023-10-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 13,351 packages |
| UPC / GTIN / UDI-DI | 10195594542153, 10195594884130, 10195594887452, 10195594963811, 10197106010419, 10197106087619, 10197106161418, 10197106186930, 10887488777795, 10888439847475, 10888439898071, 10888439906561, 10888439910209, 10888439910216, 10888439925708, 10888439948707 |
| Lot numbers | 4316, 81580, 895495, 914590, 916606, 920956, 923138, 928044, 928313, 930337, 966904, 984246, 986052, 987163, 997330, 997386 |
| Model numbers | BA18GLEFF, OT18CYEFC, OT29GUHCD, OT30PENBB, OT33PNO13, OT33PNO15, OT51CPK10, OT51CPKOA, OT69PCKSA, OT73CPKSB, OT7APNLVB, PG33BTO21, PG33BTO22, PG33SROUB |
| Expiration dates | 2023-11-01, 2024-02-01, 2024-03-01, 2024-05-01, 2024-06-01, 2024-08-01, 2024-12-01, 2025-01-01, 2025-02-01, 2025-06-01, 2025-07-01, 2025-08-01, 2027-04-01, 2027-06-01 |
Product
Procedure packs: (1) Presource PBDS Cat. PG33BTO21, Ohio State Univ Wexner Med Ctr, Kit, Roux UH, Sterile; (2) Presource PBDS Cat. PG33BTO22, Ohio State Univ Wexner Med Ctr, Kit, Roux UH, Sterile; (3) Presource PBDS Cat. PG33SROUB, Ohio State Univ Wexner Med Ctr, Kit, Robot Surg Onc, Sterile; (4) Presource PBDS Cat. PUMHCCESP, Southeast Hospital MHHS, Kit, Cystoscopy, SE, Sterile; (5) Presource General Laparoscopy Pack, Cat. SBA18GLEFF, St. Elizabeth Medical Center, Sterile; (6) Presource IUS Perc 1 Pk, Cat. SOTCGPPMEA, IU Health Methodist Hospital, Sterile; (7) Presource Cysto Pack, Cat. SOT18CYEFC, St. Elizabeth Medical Center; Sterile (8) Presource GU PUP Pack, Cat. SOT29GUHCD, Hillcrest Hospital, Sterile; (9) Presource PCNL Pack, Cat. SOT30PENBB, North Bay Regional Hlth Ctr, Sterile; (10) Presource Percu Nephros Lithotomy UH Pk, Cat. SOT33PNO13, Ohio State Univ Wexner Med Ctr., Sterile; (11) Presource Percu Nephros Lithotomy UH Pk, Cat. SOT33PNO15, Ohio State Univ Wexner Med Ctr., Sterile; (12) Presource PNL Cysto Pack, Cat. SOT51CPKOA, KP Oakland Med Center, Sterile; (13) Presource PNL Cysto Pack, Cat. SOT51CPK10, KP Oakland Med Center, Sterile; (14) Presource PCN Pack, Cat. SOT69PCKSA, KP Los Angeles Med Center, Sterile; (15) Presource Perc Neph Pack, Cat. SOT7APNLVB, Lehigh Valley Hospital, Sterile; and (16) Presource Cysto Pack, Cat. SOT73CPKSB, KP Zion Med Cntr, Sterile.
Reason for recall
Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0086-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.