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Sources: EU EUDAMED, US FDA
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Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2. 8888571513 Cardinal Health Sentinel Seal CDU, Dual Drain 3. 8888571489 Cardinal Health Sentinel Seal CDU, with Easy Change Connector 4. 8888571370 Cardinal Health Altitude CDU, Dry Suction, with Easy Change Connector 5. 8888571299 Cardinal Health Aqua-Seal CDU, Wet Suction 6. 8888571406 Cardinal Health Aqua-Seal CDU, Wet Suction, Dual Drain 7. 8888571315 Cardinal Health Aqua-Seal CDU, Wet Suction, with Easy Change Connector 8. 8884713100 Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL 9. 1814713105 OUSOnly - Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL (Bottle only) 10. 1180571570 OUSOnly - Cardinal Health Thora-Seal CDU, Two Chamber System, 2600 mL 11. 8884713308 Cardinal Health Thora-Seal CDU, Three Chamber System, 2500 mL 12. 8884713900 Cardinal Health Thora-Seal Replacement Collection Chamber, 2500 mL
FDA Recall
Open, Classified
·Cardinal Health 200, LLC·Product code GCX·December 26, 2025
Cardinal Health Alaris Pump Module (formerly Medley Pump Module), Model 8100, Cardinal Health, San Diego, CA. (All Alaris Pump modules shipped prior to December 23, 2007 are subject to this recall)
FDA Recall
Terminated
·Cardinal Health 303 Inc DBA Alaris Products·Product code FRN·October 29, 2007
Cardinal Health EnVe Ventilator Cat # 19250-001, Manufactured by Cardinal Health, Minneapolis, MN 55447-1341. Intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.
FDA Recall
Terminated
·Product code CBK·January 8, 2010
All IV Administration Infusion Sets intended for use with the Gemini Infusion Pump and Alaris Pump module (a.k.a. Medley Pump module) including: Alaris SmartSite Low Sorbing Set, Alaris Vented Syringe Adapter Set, Alaris Burette Set, Cardinal Health SmartSite Infusion Set, Alaris Infusion Set, Alaris SmartSite Burette Set, Cardinal Health SmartSite Burette Set, Alaris SmartSite Administration Set, Alaris Infusion Burette Set, Alaris SmartSite Blood Set, Cardinal Health SmartSite Combination Infusion Set, Cardinal Health Blood Set, Alaris Medley/Gemini Infusion Set, Alaris Medley/Gemini Blood Set, Alaris Latex-Free Infusion Set, Alaris Light Sensitive Solution Set, Alaris Medley/Gemini Enteral Set, Imed Gemini 20 Vented/Nonvented Primary Administration Set, Imed Vented/Nonvented Gemini Prime-Saver Set, Imed Vented/Nonvented Gemini Short Set, Alaris Half Set, Cardinal Health Half Set, Alaris Latex-Free Burette Set, Alaris Opaque Set, Alaris Medley/Gemini Combination Infusion Set
FDA Recall
Terminated
·Cardinal Health 303 Inc DBA Alaris Products·Product code FRN·June 18, 2007
Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent.
FDA Recall
Terminated
·Product code JIN·July 12, 2021
Cardinal Health GEL PACK REUSABLE, SMALL, Cat. 70204
FDA Recall
Open, Classified
·Cardinal Health 200, LLC·Product code IME·September 28, 2022
Cardinal Health INSULATED GEL PACK REUSABLE, SMALL, Cat. 80204A
FDA Recall
Open, Classified
·Cardinal Health 200, LLC·Product code IME·September 28, 2022
Cardinal Health Presource Kits: 1) LARYNGOSCOPY PACK, Catalog Number:SRIET0979N;
FDA Recall
Open, Classified
·Cardinal Health 200, LLC·Product code OGH·November 8, 2024
Cardinal Health INSULATED GEL PACK REUSABLE, MEDIUM, Cat. 80304A
FDA Recall
Open, Classified
·Cardinal Health 200, LLC·Product code IME·September 28, 2022
Cardinal Health GEL PACK REUSABLE, EXTRA SMALL, Cat. 61115
FDA Recall
Open, Classified
·Cardinal Health 200, LLC·Product code IME·September 28, 2022
Cardinal Health INSULATED GEL PACK REUSABLE, LARGE, Cat. 80104
FDA Recall
Open, Classified
·Cardinal Health 200, LLC·Product code IME·September 28, 2022
Cardinal Health Tiny Toes; 11470-010T Infant heel warmer
FDA Recall
Terminated
·Philips Electronics North America Corporation·Product code IMD·November 20, 2015
Cardinal Health Poly-Reinforced Surgical Gowns Large SKU: 9010
FDA Recall
Open, Classified
·Cardinal Health·Product code FYA·November 2, 2021
Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves
FDA Recall
Completed
·Cardinal Health 200, LLC·Product code KGO·March 15, 2022
Cardinal Health Poly-Reinforced Surgical Gowns X-large SKU: 9040
FDA Recall
Open, Classified
·Cardinal Health·Product code FYA·November 2, 2021
Cardinal Health INSULATED GEL PACK REUSABLE, EXTRA LARGE, Cat. 80600
FDA Recall
Open, Classified
·Cardinal Health 200, LLC·Product code IME·September 28, 2022
Cardinal Health Poly-Reinforced Surgical Gowns XX-large SKU: 9070
FDA Recall
Open, Classified
·Cardinal Health·Product code FYA·November 2, 2021
Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2230
FDA Recall
Open, Classified
·Cardinal Health 200, LLC·Product code GBX·December 14, 2022
Cardinal Health HOT AND COLD GEL PACK REUSABLE, M, Cat. 70304
FDA Recall
Open, Classified
·Cardinal Health 200, LLC·Product code IME·September 28, 2022
Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2217
FDA Recall
Open, Classified
·Cardinal Health 200, LLC·Product code GBX·December 14, 2022