{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "202934", "product_res_number": "Z-0086-2024", "event_date_initiated": "2023-08-16", "event_date_posted": "2023-10-10", "recall_status": "Open, Classified", "res_event_number": "92875", "product_code": "FDE", "product_description": "Procedure packs:\n\n(1) Presource PBDS Cat. PG33BTO21, Ohio State Univ Wexner Med Ctr, Kit, Roux UH, Sterile; \n(2) Presource PBDS Cat. PG33BTO22, Ohio State Univ Wexner Med Ctr, Kit, Roux UH, Sterile; \n(3) Presource PBDS Cat. PG33SROUB, Ohio State Univ Wexner Med Ctr, Kit, Robot Surg Onc, Sterile;\n(4) Presource PBDS Cat. PUMHCCESP, Southeast Hospital MHHS, Kit, Cystoscopy, SE, Sterile;\n(5) Presource General Laparoscopy Pack, Cat. SBA18GLEFF, St. Elizabeth Medical Center, Sterile;\n(6) Presource IUS Perc 1 Pk, Cat. SOTCGPPMEA, IU Health Methodist Hospital, Sterile;\n(7) Presource Cysto Pack, Cat. SOT18CYEFC, St. Elizabeth Medical Center; Sterile\n(8) Presource GU PUP Pack, Cat. SOT29GUHCD, Hillcrest Hospital, Sterile;\n(9) Presource PCNL Pack, Cat. SOT30PENBB, North Bay Regional Hlth Ctr, Sterile;\n(10) Presource Percu Nephros Lithotomy UH Pk, Cat. SOT33PNO13, Ohio State Univ Wexner Med Ctr., Sterile;\n(11) Presource Percu Nephros Lithotomy UH Pk, Cat. SOT33PNO15, Ohio State Univ Wexner Med Ctr., Sterile;\n(12) Presource PNL Cysto Pack, Cat. SOT51CPKOA, KP Oakland Med Center, Sterile;\n(13) Presource PNL Cysto Pack, Cat. SOT51CPK10, KP Oakland Med Center, Sterile;\n(14) Presource PCN Pack, Cat. SOT69PCKSA, KP Los Angeles Med Center, Sterile;\n(15) Presource Perc Neph Pack, Cat. SOT7APNLVB, Lehigh Valley Hospital, Sterile; and \n(16) Presource Cysto Pack, Cat. SOT73CPKSB, KP Zion Med Cntr, Sterile.", "code_info": "(1) Cat. PG33BTO21 - Lot #914590, Exp. 6/1/2024, UDI-DI 10195594884130; \n(2) Cat. PG33BTO22 - Lot #928313, Exp. 2/1/2024, UDI-DI 10197106010419; \n(3) Cat. PG33SROUB - Lot #81580, Exp. 12/1/2024, UDI-DI 10197106186930; \n(4) Cat. PUMHCCESP - Lot #4316, Exp. 2/1/2025 and 9/1/2025, UDI-DI 10195594542153;\n(5) Cat. SBA18GLEFF - Lot #895495, Exp. 6/1/2025 and Exp. 7/1/2025, UDI-DI 10888439910209;\n(6) Cat. SOTCGPPMEA - Lot #984246, Exp. 7/1/2025 and Exp. 5/1/2024, UDI-DI 10888439847475;\n(7) Cat. SOT18CYEFC - Lot #928044, Exp. 4/1/2027, UDI-DI 10888439910216;\n(8) Cat. SOT29GUHCD - Lot #986052, Exp. 6/1/2027, UDI-DI 10195594963811; \n(9) Cat. SOT30PENBB - Lot #987163, Exp. 8/1/2025, UDI-DI 10888439948707; \n(10) Cat. SOT33PNO13 - Lot #920956, Exp. 8/1/2024, UDI-DI 10195594887452; \n(11) Cat. SOT33PNO15 - Lot #966904, Exp. 6/1/2024, UDI-DI 10197106087619; \n(12) Cat. SOT51CPKOA - Lot #916606, Exp. 11/1/2023, UDI-DI 10887488777795; \n(13) Cat. SOT51CPK10 - Lot #997330, Exp. 2/1/2024, UDI-DI 10197106161418; \n(14) Cat. SOT69PCKSA - Lot #997386, Exp. 3/1/2024, UDI-DI 10888439898071; \n(15) Cat. SOT7APNLVB - Lot #930337, Exp. 5/1/2024, UDI-DI 10888439925708; and\n(16) Cat. SOT73CPKSB - Lot #923138 Exp. 1/1/2025, UDI-DI 10888439906561.", "firm_fei_number": "3001236905", "recalling_firm": "Cardinal Health 200, LLC", "address_1": "3651 Birchwood Dr", "city": "Waukegan", "state": "IL", "postal_code": "60085-8337", "additional_info_contact": "800-292-9332", "reason_for_recall": "Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).", "root_cause_description": "Material/Component Contamination", "action": "The recalling firm issued letters dated 8/17/2023 via overnight mail on 8/16/2023. The letter explained the reason for recall, risk to health, and the actions required and included a copy of the supplier's letter. The actions were for the consignee to (1) review their inventory for the affected catalog and lot numbers in the enclosed attachment; (2) segregate and quarantine the affected product and follow instructions in the letter for product return; (3)notify any customers to whom they may have distributed/forwarded the affected product and share a copy of the recall letter to notify them; and (4) return the enclosed acknowledgment form via FAX or email as to whether they have the affected product. Instructions for contacting the appropriate Customer Service groups are provided to arrange for return and credit/replacement of the affected product. An example of a label is provided to show where to find the catalog number, lot number, and expiration date.", "product_quantity": "13,351 total packs", "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.", "openfda": { "k_number": [ "K912443", "K942677", "K955717", "K950924" ], "device_name": "Laparoscopy Kit", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2", "registration_number": [ "3007289408", "3005595283", "2029015", "1060680", "3014925393", "1055236", "3004605321", "3007329020", "1643817", "3009888344", "2433012", "3003418325", "1030451", "3004111573", "3014325891", "3004911384", "3045816907", "1047429", "9611102", "1423537", "1043214", "3015895045", "3008513424", "1928237", "1423395", "3016832577", "3004362278", "3015612252", "9616088", "3013868968", "3035642068", "3015058854", "1054241", "3010041511", "3015241782", "3011063460", "3005012805", "3011137372", "3015173212", "1061124", "3010885402", "3004122598", "2320762", "3045816902", "1418479", "2431166", "3001675293" ], "fei_number": [ "1000160458", "3007289408", "3000717925", "3005595283", "3002902735", "3005747797", "3014925393", "3004605321", "1000112877", "2523865", "3001236905", "3007329020", "1643817", "1000208624", "3009888344", "2433012", "3003418325", "1030451", "3004111573", "3014325891", "3004911384", "3045816907", "1047429", "3003040625", "1043214", "1000112968", "3015895045", "3008513424", "1928237", "3016832577", "3004362278", "3015612252", "3013868968", "3035642068", "1000512168", "3015058854", "3010041511", "3015241782", "3011063460", "3005012805", "3015173212", "3010885402", "1418479", "3004122598", "3045816902", "3002808001", "3001675293" ] } } ] }