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Cardinalhealth

Last updated September 17, 2026

What Cardinalhealth makes

The company manufactures reusable electrocardiographic lead sets, nasoenteral and gastrostomy feeding tubes, adult indwelling urethral catheterization kits, non-woven gauze pads, single-use transcutaneous electrical stimulation electrodes, disposable incontinence pants, and medicine bottles. It also produces nitrile examination gloves labeled for chemotherapy drug compatibility, radiopaque bone cement, and various wound care and urinary drainage products under branded lines such as Devon, Kendall, Kangaroo, Argyle, SharpSafety, and Uni-Patch.

These devices are regulated under FDA classifications including Class I, Class II, and unclassified (U), with submissions recorded in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. The company operates from the United States, where its products are tracked in the relevant regulatory registries.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
Address: 8322 Eagle Palm Drive, Riverview, FL, 33578
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3011200334
DUNS Number: —

Catalogue (4967)

Page 99 of 100

Device	Model / Reference	Registries	Class	Status
Monoject	8881535101	FDA UDI	Class II	Unknown
Dover	1814	FDA UDI	Class II	Unknown
Argyle	423879	FDA UDI	Class II	Active
Uni-Patch	EP85215	FDA UDI	Class II	Active
Argyle	5558572060	FDA UDI	Class II	Active
Monoject	8881250123	FDA UDI	Class II	Active
Monoject	1180125158	FDA UDI	Class II	Active
Dover	8887689225	FDA UDI	Class II	Active
Monoject	8881112083	FDA UDI	Class II	Unknown
Filac	202020	FDA UDI	Class II	Unknown
Cardinal Health NPWT PRO HC	K150124	FDA 510(k)	Class II	Active
Airlife Misty Finity Large Volume Continuous Nebulizer	K041418	FDA 510(k)	Class II	Active
Kendall NPWT Incision Management Dressing Kit	K191101	FDA 510(k)	Class II	Active
Protexis Latex Blue With Neu-Thera Powder-Free Surgical Gloves	K111878	FDA 510(k)	Class I	Active
Sterile Polyisoprene Powder-Free Surgical Gloves Tested For Use With Chemotherapy Drug	K110272	FDA 510(k)	Class I	Active
Esteem Smt Polyisoprene Powder-Free Surgical Sterile Gloves	K093300	FDA 510(k)	Class I	Active
Spetzler Scalp Retractor Clamps (various Styles And Sizes)	K090272	FDA 510(k)	Class II	Active
Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse Gown	K211765	FDA 510(k)	Class II	Active
Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating	K160411	FDA 510(k)	Class I	Active
Protexis Latex Basic Sterile Powder-Free Surgical Gloves	K121897	FDA 510(k)	Class I	Active
Cardinal Health Protegrity Blue With Neu-Thera Surgical Gloves	K053272	FDA 510(k)	Class I	Active
Occlusion Detection Dressing Kit	K171499	FDA 510(k)	Class II	Active
Kangaroo OMNI™ Enteral Feeding Pump (385400 );Kangaroo OMNI™ Feeding Set 500ml (B5FD );Kangaroo OMNI™ ENtelliSet 500ml (E5FD );Kangaroo OMNI™ Feeding Set 1000ml (B10FD );Kangaroo OMNI™ ENtelliSet 1000ml (E10FD );Kangaroo OMNI™ ENPlus Spike Set (BSPFD );Kangaroo OMNI™ ENtelliSet ENPlus Spike ( ESPFD );Kangaroo OMNI™ Feeding Set 500ml with Flush Bag ( B5FF);Kangaroo OMNI™ ENtelliSet 500ml with Flush Bag (E5FF);Kangaroo OMNI™ Feeding Set 1000ml with Flush Bag ( E10FF );Kangaroo OMNI™	K221603	FDA 510(k)	Class II	Active
Tiburon Drape, Model 9349n/ Optima Drape, Model 9446n	K061762	FDA 510(k)	Class II	Active
Coaxial Bone And Vertebral Body Biopsy Needle Model# Jbc1213, Jbc1208	K070091	FDA 510(k)	Class II	Active
Inflatable Bone Tamp	K090211	FDA 510(k)	Class II	Active
Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject™ 3mL Syringe, Luer-Lock Tip (1180300777); Monoject™ 6mL Syringe, Luer-Lock Tip (1180600777); Monoject™ 12mL Syringe, Luer-Lock Tip (1181200777); Monoject™ 20mL Syringe, Luer-Lock Tip (1182000777); Monoject™ 35mL Syringe, Luer-Lock Tip (1183500777); Monoject™ 60mL Syringe, Luer-Lock Tip (1186000777); Monoject™ 3mL Syringe, Luer-Lock Tip (8881513934); Monoject™ 6mL Syringe , Luer-Lock Tip (8881516937); Monojec	K243660	FDA 510(k)	Class II	Active
Sterile Water For Inhalation Flex Bag, Usp	K090915	FDA 510(k)	Class II	Active
Esteem Stretchy Vinyl Glove With Coating	K052568	FDA 510(k)	Class I	Active
Salem Sump Dual Lumen Stomach Tube with ENFit Connection	K190923	FDA 510(k)	Class II	Active
Bone Cement For Cranioplasty	K040152	FDA 510(k)	Class II	Active
Nicolet Cortical Stimulator	K072964	FDA 510(k)	Class II	Active
Nitrile Powder-Free Examination Gloves With Lotion Coating And Use For Chemotherapy	K032444	FDA 510(k)	Class I	Active
Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set	K161418	FDA 510(k)	Class II	Active
Sterile Neoprene Powder-Free Surgical Gloves With Nitrile Coating	K102500	FDA 510(k)	Class I	Active
Esteem Sterile Polyisoprene Surgical Gloves With Coating	K031301	FDA 510(k)	Class I	Active
Cardinal Health External Fixation System	K150579	FDA 510(k)	Class II	Active
Kendall NPWT Incision Management Device	K202217	FDA 510(k)	Class II	Active
Airlife Infant Nasal Continuous Positive Airway Pressure System	K050994	FDA 510(k)	Class II	Active
Esteem Blue Polyisoprene Surgical Gloves With Coating (containing Chitosan, Provitamin B, Gluconolactone And Glycerol)	K042574	FDA 510(k)	Class I	Active
SVED Wound Treatment System	K142916	FDA 510(k)	Class II	Active
Avaflex Vertebral Augmentation Needle	K072133	FDA 510(k)	Class II	Active
Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection	K213174	FDA 510(k)	Class II	Active
Bone Cement Radio-Opacifier	K032388	FDA 510(k)	Class II	Active
Airlife Nebulizer Cap	K072119	FDA 510(k)	Class II	Active
Cardinal Health Trochanteric IM Nail System	K150769	FDA 510(k)	Class II	Active
Nitrile Powder-Free Examination Gloves Tested For Use With Chemotherapy Drugs	K110921	FDA 510(k)	Class I	Active
Protegrity Steile Latex Surgical Gloves With Coating	K033905	FDA 510(k)	Class I	Active
Cardinal Health Nitrile Examination Gloves Extended Cuff	K252313	FDA 510(k)	Class I	Active
Protegrity Smt Latex Surgicalgloves	K101811	FDA 510(k)	Class I	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

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Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (100)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Cardinal Health has 199 recall records initiated between June 2, 2003, and November 1, 2022, with statuses including completed, open, classified, and terminated. Recalled items involved issues such as improper storage conditions, non-compliance with flammability standards, incorrect assembly or sterilization, labeling errors, missing FDA registrations for components, manufacturing defects affecting sterility, and products shipped without sterilization. Reasons also included inadvertent release of products under regulatory holds and mislabeled packaging.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Nov 1, 2022	Z-0360-2023	—	open, classified	Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention
Nov 1, 2022	Z-0358-2023	—	open, classified	Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention
Nov 1, 2022	Z-0356-2023	—	open, classified	Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention
Nov 1, 2022	Z-0361-2023	—	open, classified	Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention
Nov 1, 2022	Z-0359-2023	—	open, classified	Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention
Nov 1, 2022	Z-0357-2023	—	open, classified	Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention
Nov 2, 2021	Z-0374-2022	—	open, classified	Potential for open packaging seals compromising the sterility of the surgical gowns
Nov 2, 2021	Z-0368-2022	—	open, classified	Potential for open packaging seals compromising the sterility of the surgical gowns
Nov 2, 2021	Z-0371-2022	—	open, classified	Potential for open packaging seals compromising the sterility of the surgical gowns
Nov 2, 2021	Z-0373-2022	—	open, classified	Potential for open packaging seals compromising the sterility of the surgical gowns
Nov 2, 2021	Z-0370-2022	—	open, classified	Potential for open packaging seals compromising the sterility of the surgical gowns
Nov 2, 2021	Z-0376-2022	—	open, classified	Potential for open packaging seals compromising the sterility of the surgical gowns
Nov 2, 2021	Z-0372-2022	—	open, classified	Potential for open packaging seals compromising the sterility of the surgical gowns
Nov 2, 2021	Z-0377-2022	—	open, classified	Potential for open packaging seals compromising the sterility of the surgical gowns
Nov 2, 2021	Z-0369-2022	—	open, classified	Potential for open packaging seals compromising the sterility of the surgical gowns
Nov 2, 2021	Z-0378-2022	—	open, classified	Potential for open packaging seals compromising the sterility of the surgical gowns
Nov 2, 2021	Z-0375-2022	—	open, classified	Potential for open packaging seals compromising the sterility of the surgical gowns
Aug 4, 2021	Z-2285-2021	—	open, classified	Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
Aug 4, 2021	Z-2284-2021	—	open, classified	Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
Aug 4, 2021	Z-2286-2021	—	open, classified	Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
Jun 16, 2021	Z-2244-2021	—	terminated	The current Argyle UVC Insertion Tray does not include a specific IFU to operate the Safety Scalpel N11. The Safety Scalpel N11 features a permanent locking feature that will not allow the clinician to unlock the scalpel once the safety shield is closed and pushed forward into a locked position may result in a delay treatment/therapy, which could ultimately result in death.
Jun 9, 2021	Z-2095-2021	—	terminated	A caution statement is being added to remind the user to activate away from face and infant as reports of pack rupture or leaking during activation may resulting in the contents splashing into the user s eyes or onto the infant. Potential harms associated with contact of the liquid inside the pouch are rash, burn and inflammation.
Jun 9, 2021	Z-2094-2021	—	terminated	A caution statement is being added to remind the user to activate away from face and infant as reports of pack rupture or leaking during activation may resulting in the contents splashing into the user s eyes or onto the infant. Potential harms associated with contact of the liquid inside the pouch are rash, burn and inflammation.
Mar 16, 2021	Z-1938-2021	—	open, classified	Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Mar 16, 2021	Z-1929-2021	—	open, classified	Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Mar 16, 2021	Z-1935-2021	—	open, classified	Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Mar 16, 2021	Z-1941-2021	—	open, classified	Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Mar 16, 2021	Z-1934-2021	—	open, classified	Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Mar 16, 2021	Z-1940-2021	—	open, classified	Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Mar 16, 2021	Z-1931-2021	—	open, classified	Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Mar 16, 2021	Z-1933-2021	—	open, classified	Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Mar 16, 2021	Z-1942-2021	—	open, classified	Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Mar 16, 2021	Z-1937-2021	—	open, classified	Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Mar 16, 2021	Z-1936-2021	—	open, classified	Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Mar 16, 2021	Z-1932-2021	—	open, classified	Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Mar 16, 2021	Z-1939-2021	—	open, classified	Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Mar 16, 2021	Z-1930-2021	—	open, classified	Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Feb 9, 2021	Z-1251-2021	—	terminated	Safety shield not locking into the cannula. If the safety shield activation fails to lock a contaminated needle, a needlestick may occur and there is the potential for exposure to bloodborne pathogens
Feb 9, 2021	Z-1250-2021	—	terminated	Safety shield not locking into the cannula. If the safety shield activation fails to lock a contaminated needle, a needlestick may occur and there is the potential for exposure to bloodborne pathogens
Feb 9, 2021	Z-1252-2021	—	terminated	Safety shield not locking into the cannula. If the safety shield activation fails to lock a contaminated needle, a needlestick may occur and there is the potential for exposure to bloodborne pathogens
Sep 25, 2020	Z-0424-2021	—	terminated	Potential for the needle to detach from the cartridge after the bottom of the cartridge is twisted and removed. If the needle is not securely seated, the needle can fall out of the sheath and cause the unused needle to project out of the cartridge, and result in a needle stick/puncture from the clean/unused needle
Sep 22, 2020	Z-0452-2021	—	open, classified	The feeding spike sets may leak at the interface of the tube and spike connector.
Sep 22, 2020	Z-0453-2021	—	open, classified	The feeding spike sets may leak at the interface of the tube and spike connector.
Apr 20, 2020	Z-2049-2020	—	terminated	Three products requiring refrigerated storage conditions were incorrectly stored outside of approved temperature ranges. Using these temperature abused products may result in misdiagnosis of the patient.
Apr 20, 2020	Z-2051-2020	—	terminated	Three products requiring refrigerated storage conditions were incorrectly stored outside of approved temperature ranges. Using these temperature abused products may result in misdiagnosis of the patient.
Apr 20, 2020	Z-2050-2020	—	terminated	Three products requiring refrigerated storage conditions were incorrectly stored outside of approved temperature ranges. Using these temperature abused products may result in misdiagnosis of the patient.
Jan 15, 2020	Z-1454-2020	—	terminated	Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR" ; the product did not undergo sterilization process and is non-sterile. The usage of a needle that is not sterile could result in infection. Firm is not aware of any reports of patient harm.
Jan 15, 2020	Z-1455-2020	—	terminated	Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR" ; the product did not undergo sterilization process and is non-sterile. The usage of a needle that is not sterile could result in infection. Firm is not aware of any reports of patient harm.
Jan 15, 2020	Z-1453-2020	—	terminated	Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR" ; the product did not undergo sterilization process and is non-sterile. The usage of a needle that is not sterile could result in infection. Firm is not aware of any reports of patient harm.
Jan 15, 2020	Z-1456-2020	—	terminated	Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR" ; the product did not undergo sterilization process and is non-sterile. The usage of a needle that is not sterile could result in infection. Firm is not aware of any reports of patient harm.
Jan 11, 2020	Z-1018-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1017-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1031-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1028-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1007-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1016-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1029-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1002-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1011-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1027-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1019-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1036-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1021-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1012-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1037-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1032-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1013-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1040-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1024-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1034-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1022-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1026-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1023-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1033-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1025-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1035-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1006-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1014-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1039-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1004-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1015-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1003-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1010-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1038-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1030-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1005-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1009-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1008-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1020-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Dec 26, 2019	Z-2105-2020	—	open, classified	The feeding spike sets may leak at the interface of the tube and spike connector.
Dec 26, 2019	Z-2104-2020	—	open, classified	The feeding spike sets may leak at the interface of the tube and spike connector.
Dec 26, 2019	Z-2101-2020	—	open, classified	The feeding spike sets may leak at the interface of the tube and spike connector.
Dec 26, 2019	Z-2103-2020	—	open, classified	The feeding spike sets may leak at the interface of the tube and spike connector.
Dec 26, 2019	Z-2102-2020	—	open, classified	The feeding spike sets may leak at the interface of the tube and spike connector.
Dec 26, 2019	Z-2100-2020	—	open, classified	The feeding spike sets may leak at the interface of the tube and spike connector.
Nov 14, 2019	Z-0729-2020	—	open, classified	Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI information on the IFU. The correct classification is "MRI Conditional" not "MRI Safe".
Nov 14, 2019	Z-0730-2020	—	open, classified	Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI information on the IFU. The correct classification is "MRI Conditional" not "MRI Safe".
Nov 14, 2019	Z-0728-2020	—	open, classified	Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI information on the IFU. The correct classification is "MRI Conditional" not "MRI Safe".
Oct 28, 2019	Z-0991-2020	—	terminated	The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range ( 0.2C for Genius 2 and 0.3C for Genius 3 thermometers). The measurement readings drift upwards over time, which means that the thermometers could exceed the upper stated accuracy tolerance of +0.2C for Genius 2 or +0.3C for Genius 3.
Oct 28, 2019	Z-0990-2020	—	terminated	The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range ( 0.2C for Genius 2 and 0.3C for Genius 3 thermometers). The measurement readings drift upwards over time, which means that the thermometers could exceed the upper stated accuracy tolerance of +0.2C for Genius 2 or +0.3C for Genius 3.

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Cardinal Health DELAND, FL · US FEI 1017768