Procedure packs: — Class II medical device recall Z-0087-2024
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-0087-2024 |
|---|---|
| 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 | 10195594133559, 10195594513665, 10195594514259, 10195594542757, 10195594578916, 10195594735999, 10195594759766, 10195594882334, 10195594891275, 10195594892210, 10197106032978, 10197106279342, 10887488892696, 10887488946573, 10888439902877, 10888439903133, 10888439912135 |
| Lot numbers | 17915, 18365, 46817, 54698, 919439, 919471, 920306, 921655, 921831, 922735, 937398, 940845, 953055, 981380, 985693, 986205, 998437 |
| Model numbers | BA30MJCHH, BA41ALFME, BA44ACWBF, BA54LADN3, BA54LADNA, BAOCRBEN8, CV30THLHA, MA57PR00B, NE69LPKVB, OP26KPMHB, ORC511687B, OT30PELCA, PG63CCC31, PG63CCC34, PGVGLBP20 |
| Expiration dates | 2023-09-01, 2024-01-01, 2024-02-01, 2024-04-01, 2024-06-01, 2024-07-01, 2024-08-01, 2024-09-01, 2024-10-01, 2024-12-01, 2025-01-01, 2025-02-01, 2025-03-01, 2025-04-01, 2026-03-01 |
Product
Procedure packs: (1) Presource PBDS, Cat. PGMHSUESR, Southeast Hospital MHHS, Kit, Set Up No Drape, SE, Sterile; (2) Presource PBDS Cat. PGVGLBP20, Parkview Medical Center, Kit, Lap Chole, Sterile; (3) Presource PBDS Cat. PG63CCC31, USPI Christ Hosp Spine Srgry C, Kit, Basic, Sterile; (4) Presource PBDS Cat. PG63CCC34, USPI Christ Hosp Spine Srgry C, Kit, Basic, Sterile; (5) Presource Robotic Module Pack, Cat. SBAOCRBENF, Englewood Hospital and Medical, Sterile; (6) Presource Robotic Module Pack, Cat. SBAOCRBEN8, Englewood Hospital and Medical, Sterile; (7) Presource FMC Liver Resection Pack, Cat. SBA30MJCHH, AHS Calgary Zone, Sterile; (8) Presource ALIF Pack, Cat. SBA41ALFME, USPI Baylor Med Ctr at Fri, Sterile; (9) Presource ACDF Pack, Cat. SBA44ACWBF, Webster Surgical Specialty Hos, Sterile; (10) Presource Lap Chole Pack, Cat. SBA54LADNA, USPI Paso Del Norte Srgry Ctr, Sterile; (11) Presource Lap Chole Pack, Cat. SBA54LADN3, USPI Paso Del Nrte Srgry Ctr, Sterile; (12) Presource Salle Hybride Ensemble, Cat. SCV30THLHA, Inst Univ Cardio ET Pneumo, Sterile; (13) Presource AMB Perc Pack, Cat. SMA57PR00B, Oregon Health Science Universi, Sterile; (14) Presource KP Vacaville Lami Pack, Cat. SNE69LPKVB, KP Vacaville, Sterile; (15) Presource Kyphoplasty Pack, Cat. SOP26KPMHB, Moffitt Cancer Center, Sterile; (16) Presource Percutaneous Nephro Pack, Cat. SOT30PELCA, Lakeridge Health Corporation, Sterile; and (17) Presource PBDS Infection Control Turnover Kit, Cat. ORC511687B, Sequoia Surgery Center LLC, 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-0087-2024. 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.