Z-0087-2024 Class II Ongoing
FDA device recall Z-0087-2024 was initiated by Cardinal Health 200, LLC on August 16, 2023 and is designated Class II. Reason for recall: Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits). The recall status is ongoing. Affected quantity: 13,351 total packs.
Recall Details
- Product Type
- Devices
- Report Date
- October 18, 2023
- Initiation Date
- August 16, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,351 total packs
Product Description
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).
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, DC, FL, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, and WV. There was government distribution and no military distribution. The country of Canada.
Code Information
(1) Cat. PGMHSUESR - Lot #54698, Exp. 2/1/2025 and Exp. 6/1/2024, UDI-DI 10195594542757; (2) Cat. PGVGLBP20 - Lot #921831, Exp. 4/1/2024, UDI-DI 10195594892210; (3) Cat. PG63CCC31 - Lot #940845, Exp. 9/1/2023, UDI-DI 10197106032978; (4) Cat. PG63CCC34 - Lot #46817, Exp. 2/1/2024, UDI-DI 10197106279342; (5) Cat. SBAOCRBENF - Lot #985693, Exp. 7/1/2024, UDI-DI 10195594735999; (6) Cat. SBAOCRBEN8 - Lot #920306, Exp. 6/1/2024, UDI-DI 10195594882334; (7) Cat. SBA30MJCHH - Lot #937398, Exp. 4/1/2025, UDI-DI 10195594759766; (8) Cat. SBA41ALFME - Lot #981380, Exp. 12/1/2024, UDI-DI 10887488946573; (9) Cat. SBA44ACWBF - Lot #986205, Exp. 10/1/2024, UDI-DI 10888439902877; (10) Cat. SBA54LADNA - Lot #998437, Exp. 3/1/2026, UDI-DI 10888439912135; (11) Cat. SBA54LADN3 - Lot #921655, Exp. 2/1/2024, UDI-DI 10195594891275; (12) Cat. SCV30THLHA - Lot #919439, Exp. 1/1/2024, UDI-DI 10195594133559; (13) Cat. SMA57PR00B - Lot #922735, Exp. 3/1/2025, UDI-DI 10195594514259; (14) Cat. SNE69LPKVB - Lot #953055, Exp. 7/1/2024, UDI-DI 10195594578916; (15) Cat. SOP26KPMHB - Lot #17915, Exp. 9/1/2024, Exp. 8/1/2024, and Exp. 1/1/2025, UDI-DI 10888439903133; (16) Cat. SOT30PELCA - Lot #919471, UDI-DI 10195594513665; and (17) Cat. ORC511687B - Lot #18365, UDI-DI 10887488892696.