544 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Cardinal Health hCG Cassette Rapid Test, Part Number: B1077-22 (Mfg PN: 4582105026) The SP hCG Cassette Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in the early detection of pregnancy. This test is for professional use.
FDA Enforcement
Class III
·Terminated·Alere San Diego, Inc.·May 29, 2013
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
Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent.
FDA Enforcement
Class III
·Terminated·Stanbio Laboratory, LP·August 11, 2021
Cardinal Health Brand 120mL/53mm sterile, individual peel pouch specimen container with orange cap (100/pk) Catalog number: CHB13905
FDA Enforcement
Class II
·Terminated·Thermo Fisher Scientific (Monterrey)·November 13, 2019
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Cystoscopy Pack 89-6071.15
FDA Enforcement
Class II
·Terminated·Deroyal Industries, Inc. Lafollette·March 11, 2020
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Shoulder Pack 89-4751.08
FDA Enforcement
Class II
·Terminated·Deroyal Industries, Inc. Lafollette·March 11, 2020
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Kwik Kit 89-6389.06
FDA Enforcement
Class II
·Terminated·Deroyal Industries, Inc. Lafollette·March 11, 2020
Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in vitro diagnostic reagent.
FDA Enforcement
Class III
·Terminated·Stanbio Laboratory, LP·August 11, 2021
Cardinal Health Brand 120mL/53mm sterile specimen container with orange cap, 75 pieces/pack, 4 packs/case Catalog number: CHB13904
FDA Enforcement
Class II
·Terminated·Thermo Fisher Scientific (Monterrey)·November 13, 2019
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Ophthalmology CSTM PCK 89-6387.08
FDA Enforcement
Class II
·Terminated·Deroyal Industries, Inc. Lafollette·March 11, 2020
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Chronic Ear Pack 89-4393.17
FDA Enforcement
Class II
·Terminated·Deroyal Industries, Inc. Lafollette·March 11, 2020
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
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Laparoscopy Pack 89-6138.13
FDA Enforcement
Class II
·Terminated·Deroyal Industries, Inc. Lafollette·March 11, 2020
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Outpatient Major 89-3865.12;
FDA Enforcement
Class II
·Terminated·Deroyal Industries, Inc. Lafollette·March 11, 2020
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Thyroid Pack 89-6302.14
FDA Enforcement
Class II
·Terminated·Deroyal Industries, Inc. Lafollette·March 11, 2020
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC General Pack 89-6015.16
FDA Enforcement
Class II
·Terminated·Deroyal Industries, Inc. Lafollette·March 11, 2020
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Ocular Plastics Pack 89-6498.13
FDA Enforcement
Class II
·Terminated·Deroyal Industries, Inc. Lafollette·March 11, 2020
Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent.
FDA Recall
Terminated
·Product code JIN·July 12, 2021
Cardinal Health NPWT Canister with Gel 300cc, Prescription Only - Product Usage: The systems are intended for use on patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The Cardinal Health NPWT PRO family of systems provides care in the acute, extended and home care settings.
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·July 15, 2020