Is this your brand? Sign in to claim ownership.

Cardinalhealth

Last updated September 17, 2026

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 4 of 100

Device	Model / Reference	Registries	Class	Status
Kangaroo	724270	FDA UDI	Class II	Active
Simplicity	1845	FDA UDI	Class I	Active
Precision	9500SA	FDA UDI	Class I	Active
ChemoPlus	CT4025	FDA UDI	Class I	Active
Devon	31144333	FDA UDI	Class I	Active
Dover	P4P18XCSDK2	FDA UDI	Class II	Active
Monoject	8881847019	FDA UDI	Class I	Active
Argyle	8888501742	FDA UDI	Class II	Active
Devon	31146890	FDA UDI	Class II	Active
Kendall	9244	FDA UDI	Class I	Active
Kangaroo	716120	FDA UDI	Class II	Active
Monoject	8881202322	FDA UDI	Class I	Active
Monoject	1188819112	FDA UDI	Class II	Active
Kangaroo	8884720221	FDA UDI	Class II	Active
Curity	42002	FDA UDI	Class I	Active
Kangaroo	383491	FDA UDI	Class II	Active
Dover	8887605189	FDA UDI	Class II	Unknown
Argyle	8888115006	FDA UDI	Class II	Active
Devon	31160545	FDA UDI	Class I	Unknown
Kangaroo	8884721211E	FDA UDI	Class II	Active
Curity	8042G	FDA UDI	Class I	Active
Monoject	8881513918	FDA UDI	Class II	Active
Argyle	37524	FDA UDI	Class II	Active
Dover	8420	FDA UDI	Class II	Active
T.e.d.	3185LF	FDA UDI	Class II	Unknown
Dover	P4P18SD	FDA UDI	Class II	Active
Dover	605148IC	FDA UDI	Class II	Active
Salem Sump	8888264986	FDA UDI	Class II	Active
Curity	03190	FDA UDI	Class I	Active
Argyle	8888591081	FDA UDI	Class II	Active
Kangaroo	392457	FDA UDI	Class II	Active
Monoject	1180327114	FDA UDI	Class II	Active
Dover	8888492128	FDA UDI	Class II	Active
SharpSafety	8536SA	FDA UDI	Class II	Active
Dover	1514C	FDA UDI	Class II	Active
Kangaroo	716100	FDA UDI	Class II	Active
Medi-Trace Cadence	22550P	FDA UDI	Class II	Unknown
Devon	573310	FDA UDI	Class I	Active
Devon	31143319	FDA UDI	Class I	Active
Dover	400612	FDA UDI	Class II	Active
Monoject	8881301819	FDA UDI	Class II	Active
Kendall	MKN34722	FDA UDI	Class I	Active
Devon	573615	FDA UDI	Class I	Active
ChemoPlus	CTS731XL	FDA UDI	Class I	Active
Kangaroo	8884751622	FDA UDI	Class II	Active
Argyle	8888571067	FDA UDI	Class II	Active
Dover	8887606203	FDA UDI	Class II	Unknown
Kendall	33508	FDA UDI	Class II	Active
Webril	BW0304	FDA UDI	Class I	Unknown
Simplicity	1530	FDA UDI	Class I	Unknown

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

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.

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