Reported Oct 18, 2023 · Ongoing
Procedure packs
Cardinal Health 200, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cardinal Health 200, LLC · 3651 Birchwood Dr · Waukegan, IL · 60085-8337
Is this the product you have?
Procedure packs
17 of 17 products
| # | Product as published |
|---|---|
| 1 | (1) Presource PBDS, Cat. PGMHSUESR, Southeast Hospital MHHS, Kit, Set Up No Drape, SE, Sterile |
| 2 | (2) Presource PBDS Cat. PGVGLBP20, Parkview Medical Center, Kit, Lap Chole, Sterile |
| 3 | (3) Presource PBDS Cat. PG63CCC31, USPI Christ Hosp Spine Srgry C, Kit, Basic, Sterile |
| 4 | (4) Presource PBDS Cat. PG63CCC34, USPI Christ Hosp Spine Srgry C, Kit, Basic, Sterile |
| 5 | (5) Presource Robotic Module Pack, Cat. SBAOCRBENF, Englewood Hospital and Medical, Sterile |
| 6 | (6) Presource Robotic Module Pack, Cat. SBAOCRBEN8, Englewood Hospital and Medical, Sterile |
| 7 | (7) Presource FMC Liver Resection Pack, Cat. SBA30MJCHH, AHS Calgary Zone, Sterile |
| 8 | (8) Presource ALIF Pack, Cat. SBA41ALFME, USPI Baylor Med Ctr at Fri, Sterile |
| 9 | (9) Presource ACDF Pack, Cat. SBA44ACWBF, Webster Surgical Specialty Hos, Sterile |
| 10 | (10) Presource Lap Chole Pack, Cat. SBA54LADNA, USPI Paso Del Norte Srgry Ctr, Sterile |
| 11 | (11) Presource Lap Chole Pack, Cat. SBA54LADN3, USPI Paso Del Nrte Srgry Ctr, Sterile |
| 12 | (12) Presource Salle Hybride Ensemble, Cat. SCV30THLHA, Inst Univ Cardio ET Pneumo, Sterile |
| 13 | (13) Presource AMB Perc Pack, Cat. SMA57PR00B, Oregon Health Science Universi, Sterile |
| 14 | (14) Presource KP Vacaville Lami Pack, Cat. SNE69LPKVB, KP Vacaville, Sterile |
| 15 | (15) Presource Kyphoplasty Pack, Cat. SOP26KPMHB, Moffitt Cancer Center, Sterile |
| 16 | (16) Presource Percutaneous Nephro Pack, Cat. SOT30PELCA, Lakeridge Health Corporation, Sterile |
| 17 | and (17) Presource PBDS Infection Control Turnover Kit, Cat. ORC511687B, Sequoia Surgery Center LLC, Sterile. |
- Lot codes and dates
17 of 17 products
Products covered by this recall # Barcodes Product as published 1 10195594542757(1) Cat. PGMHSUESR - Lot #54698, Exp. 2/1/2025 and Exp. 6/1/2024, UDI-DI 10195594542757 2 10195594892210(2) Cat. PGVGLBP20 - Lot #921831, Exp. 4/1/2024, UDI-DI 10195594892210 3 10197106032978(3) Cat. PG63CCC31 - Lot #940845, Exp. 9/1/2023, UDI-DI 10197106032978 4 10197106279342(4) Cat. PG63CCC34 - Lot #46817, Exp. 2/1/2024, UDI-DI 10197106279342 5 10195594735999(5) Cat. SBAOCRBENF - Lot #985693, Exp. 7/1/2024, UDI-DI 10195594735999 6 10195594882334(6) Cat. SBAOCRBEN8 - Lot #920306, Exp. 6/1/2024, UDI-DI 10195594882334 7 10195594759766(7) Cat. SBA30MJCHH - Lot #937398, Exp. 4/1/2025, UDI-DI 10195594759766 8 10887488946573(8) Cat. SBA41ALFME - Lot #981380, Exp. 12/1/2024, UDI-DI 10887488946573 9 10888439902877(9) Cat. SBA44ACWBF - Lot #986205, Exp. 10/1/2024, UDI-DI 10888439902877 10 10888439912135(10) Cat. SBA54LADNA - Lot #998437, Exp. 3/1/2026, UDI-DI 10888439912135 11 10195594891275(11) Cat. SBA54LADN3 - Lot #921655, Exp. 2/1/2024, UDI-DI 10195594891275 12 10195594133559(12) Cat. SCV30THLHA - Lot #919439, Exp. 1/1/2024, UDI-DI 10195594133559 13 10195594514259(13) Cat. SMA57PR00B - Lot #922735, Exp. 3/1/2025, UDI-DI 10195594514259 14 10195594578916(14) Cat. SNE69LPKVB - Lot #953055, Exp. 7/1/2024, UDI-DI 10195594578916 15 10888439903133(15) Cat. SOP26KPMHB - Lot #17915, Exp. 9/1/2024, Exp. 8/1/2024, and Exp. 1/1/2025, UDI-DI 10888439903133 16 10195594513665(16) Cat. SOT30PELCA - Lot #919471, UDI-DI 10195594513665 17 10887488892696and (17) Cat. ORC511687B - Lot #18365, UDI-DI 10887488892696. - Amount recalled
- 13,351 total packs
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Where it was sold
Why it was recalled
Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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