Chrysalis Intelligence · Sponsors · Cardinal Health, LLC

Cardinal Health, LLC

Waukegan, IL, US · 2 510(k) clearances · 76 recalls (3 Class I)

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Total clearances
2
2021-11-23 → 2022-12-20
Last 12 months
0
Product codes
2
Most recent
2022-12-20
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
LZH Pump, Infusion, Enteral Class II General Hospital 1 2022-12-20
FYA Gown, Surgical Class II General, Plastic Surgery 1 2021-11-23
Safety

Recalls (76)

Class I (serious)
3
Risk of injury / death
Total recalls
76
Currently ongoing
34
Most recent
2022-11-01
DateSeverityStatusRecall # ProductCodeReason
2022-11-01 Class II Ongoing Z-0361-2023 Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 1000 mL Drainage Bag P… — 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 …
2022-11-01 Class II Ongoing Z-0360-2023 Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 1000 mL Drainage Bag P… — 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 …
2022-11-01 Class II Ongoing Z-0359-2023 Dover Closed Urethral Tray with Vinyl Catheter Product Code: 3420 Intended for urinary drainage from the bladder of a… — 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 …
2022-11-01 Class II Ongoing Z-0358-2023 Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 14 Fr/Ch (4.7 mm) Product Code: 3410 Intended fo… — 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 …
2022-11-01 Class II Ongoing Z-0357-2023 Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 16 Fr/Ch (5.3 mm) Product Code: 3408 Intended for … — 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 …
2022-11-01 Class II Ongoing Z-0356-2023 Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 ml) 5ml Catheter Product Code: 2480 Intended for urinary… — 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 …
2021-11-02 Class II Ongoing Z-0378-2022 RoyalSilk Non-Reinforced Surgical Gowns XXX-large, X-long SKU: 95998 — Potential for open packaging seals compromising the sterility of the surgical gowns
2021-11-02 Class II Ongoing Z-0377-2022 RoyalSilk Non-Reinforced Surgical Gowns XX-large SKU: 9578 — Potential for open packaging seals compromising the sterility of the surgical gowns
2021-11-02 Class II Ongoing Z-0376-2022 RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548 — Potential for open packaging seals compromising the sterility of the surgical gowns
2021-11-02 Class II Ongoing Z-0375-2022 RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518 — Potential for open packaging seals compromising the sterility of the surgical gowns
2021-11-02 Class II Ongoing Z-0374-2022 Cardinal Health Poly-Reinforced Surgical Gowns XX-large SKU: 9070 — Potential for open packaging seals compromising the sterility of the surgical gowns
2021-11-02 Class II Ongoing Z-0373-2022 Cardinal Health Poly-Reinforced Surgical Gowns X-large SKU: 9040 — Potential for open packaging seals compromising the sterility of the surgical gowns
2021-11-02 Class II Ongoing Z-0372-2022 Cardinal Health Poly-Reinforced Surgical Gowns Large SKU: 9010 — Potential for open packaging seals compromising the sterility of the surgical gowns
2021-11-02 Class II Ongoing Z-0371-2022 SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long SKU: 9041EL — Potential for open packaging seals compromising the sterility of the surgical gowns
2021-11-02 Class II Ongoing Z-0370-2022 SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large SKU: 9041 — Potential for open packaging seals compromising the sterility of the surgical gowns
2021-11-02 Class II Ongoing Z-0369-2022 SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011 — Potential for open packaging seals compromising the sterility of the surgical gowns
2021-11-02 Class II Ongoing Z-0368-2022 SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-line SKU: 32474 — Potential for open packaging seals compromising the sterility of the surgical gowns
2021-08-04 Class I Ongoing Z-2286-2021 Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code 8881570125 The proposed device is indic… — Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
2021-08-04 Class I Ongoing Z-2285-2021 Monoject 0.9% Sodium Chloride Flush Syringe, 3 mL Fill, STERILE, Product Code 8881570123 The proposed device is indi… — Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
2021-08-04 Class I Ongoing Z-2284-2021 Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Code 8881570121 The proposed device is ind… — Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
2021-03-16 Class II Ongoing Z-1942-2021 ACCU-CHEK SMARTVIEW 100 TEST STRIPS Item Number: 4742862 — Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause i…
2021-03-16 Class II Ongoing Z-1941-2021 OPTICHAMBER DIAMOND SPACER WITH LARGE MASK Item Number: 4742326 — Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause i…
2021-03-16 Class II Ongoing Z-1940-2021 ONETOUCH DELICA LANCETS 33G 100 COUNT Item Number: 5541628 — Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause i…
2021-03-16 Class II Ongoing Z-1939-2021 ONETOUCH DELICA LANCETS 30G 100 COUNT Item Number: 5541610 — Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause i…
2021-03-16 Class II Ongoing Z-1938-2021 ONETOUCH ULTRA TEST STRIPS 25 COUNT Item Number: 3510443 — Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause i…
2021-03-16 Class II Ongoing Z-1937-2021 ONETOUCH ULTRASOFT LANCETS 100 COUNT Item Number: 3007788 — Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause i…
2021-03-16 Class II Ongoing Z-1936-2021 ONETOUCH ULTRA BLUE TEST STRIPS 100 COUNT Item Number: 2990174 — Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause i…
2021-03-16 Class II Ongoing Z-1935-2021 VAPORIZER VICKS 1.5GAL Item Number: 2354942 — Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause i…
2021-03-16 Class II Ongoing Z-1934-2021 DEXCOM G6 SENSOR 3 PACK Item Number: 5447552 — Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause i…
2021-03-16 Class II Ongoing Z-1933-2021 BD UF PEN 32GX4MM 100 NANO Item Number: 4292272 — Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause i…
2021-03-16 Class II Ongoing Z-1932-2021 AEROCHAMBER PLS W/MASK LRG BLU Item Number: 1496033 — Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause i…
2021-03-16 Class II Ongoing Z-1931-2021 FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877 — Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause i…
2021-03-16 Class II Ongoing Z-1930-2021 FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084 — Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause i…
2021-03-16 Class II Ongoing Z-1929-2021 FREESTYLE LANCETS 28G 100CT Item Number:2975670 — Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause i…
2020-04-20 Class II Terminated Z-2051-2020 Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml, Item code Z46BX - Product Usage: Intended to detect Group B Streptoco… — Three products requiring refrigerated storage conditions were incorrectly stored outside of approved temperature ranges. Using these temperature abused products…
2020-04-20 Class II Terminated Z-2050-2020 Professional Urine Drug Control, Item code 88010 - Product Usage: The Alere Professional Cup Urine Drug Controls are com… — Three products requiring refrigerated storage conditions were incorrectly stored outside of approved temperature ranges. Using these temperature abused products…
2020-04-20 Class II Terminated Z-2049-2020 B-Hydroxybutyrate LiquiColor, Item code CH2440058 - Product Usage: Product is used for the quantitative determination of… — Three products requiring refrigerated storage conditions were incorrectly stored outside of approved temperature ranges. Using these temperature abused products…
2020-01-11 Class II Terminated Z-1040-2020 AAMI 3 FABREINF SURG GOWN LARGE, Item Code 9511 — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
2020-01-11 Class II Terminated Z-1039-2020 AAMI 3 NONREINF SURGICAL GOWN 3XL, Item Code 9585 — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
2020-01-11 Class II Terminated Z-1038-2020 AAMI 3 NON-REINF SURG GWN XL 2 TWL, Gown Item Code ASG9545 — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
2020-01-11 Class II Terminated Z-1037-2020 AAMI 3 NON-REINF SURG GOWN LG 2 TWL, Item Code ASG9515 — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
2020-01-11 Class II Terminated Z-1036-2020 AAMI 3 FABRNF SURGGWN XL LONG 2 TWL, Gown. Item Code ASG9541EL — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
2020-01-11 Class II Terminated Z-1035-2020 AAMI 3 FABRNF SURG GWN XL 2 TOWELS, Gown. Item Code ASG9541 — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
2020-01-11 Class II Terminated Z-1034-2020 AAMI 3 FABRNF SURG GOWN L 2 TOWELS, Item Code ASG9511 — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
2020-01-11 Class II Terminated Z-1033-2020 AAMI 3 NON-REINF SURGICAL GOWN XL, Item Code 9545 — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
2020-01-11 Class II Terminated Z-1032-2020 GOWN SURG LG W/TOWEL ST BACK, Item Code 9515 — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
2020-01-11 Class II Terminated Z-1031-2020 AAMI 3 NON-REINF SURG GWN 3XL XLONG, Gown. Item Code 95995 — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
2020-01-11 Class II Terminated Z-1030-2020 AAMI 3 NONREINF SURGICAL GOWN 4XL, Item Code 9599 — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
2020-01-11 Class II Terminated Z-1029-2020 AAMI 3 NONREINF SURG GOWN 2XL XLONG, Item Code 9575EL — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
2020-01-11 Class II Terminated Z-1028-2020 AAMI 3 NON-REINF SURGICAL GOWN XXL, Item Code 9575 — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
2020-01-11 Class II Terminated Z-1027-2020 ROYALSILK XLARGE, Gown. Item Code 9548 — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
2020-01-11 Class II Terminated Z-1026-2020 AAMI 3 FABRIC REINF SURG GOWN 2XL, Item Code 9571 — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
2020-01-11 Class II Terminated Z-1025-2020 AAMI 3 FABRIC REINF SURG GOWN XL, Item Code 9541 — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
2020-01-11 Class II Terminated Z-1024-2020 ROYALSILK 3XLARGE/XLONG, Gown. Item Code 95998 — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
2020-01-11 Class II Terminated Z-1023-2020 ROYALSILK 2XLARGE, Gown. Item Code 9578 — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
2020-01-11 Class II Terminated Z-1022-2020 ROYALSILK LARGE, Gown. Item Code 9518 — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
2020-01-11 Class II Terminated Z-1021-2020 AAMI 3 NONREINF SURG GOWN 3XL BNS, Item Code 9585N — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
2020-01-11 Class II Terminated Z-1020-2020 AAMI 3 NONRNF SURG GWN 2XL XLNG BNS, Item Code 9575ELNA — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
2020-01-11 Class II Terminated Z-1019-2020 AAMI 3 NONREIN SURGGOWN BNS XL, Item Code 9545NC — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
2020-01-11 Class II Terminated Z-1018-2020 AAMI 3 NONREIN SURG GOWN L BNS, Item Code 9515NB — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
2020-01-11 Class II Terminated Z-1017-2020 AAMI 3 FABRIC REINF SURG GOWN XL NS, Item Code 9541NA — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
2020-01-11 Class II Terminated Z-1016-2020 AAMI 3 NONREIN SCRBNURGOWN BNS L, Item Code 90270NB — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
2020-01-11 Class II Terminated Z-1015-2020 AAMI 3 NON-RNF SURG GOWN 3XL LONG, Item Code 95995N — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
2020-01-11 Class II Terminated Z-1014-2020 ROYALSILK 3XLARGE/XLONG NS, Gown Item Code 95998N — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
2020-01-11 Class II Terminated Z-1013-2020 AAMI 3 ROYALSILK SURGGOWN BNS 2XL, Item Code 9578NB — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
2020-01-11 Class II Terminated Z-1012-2020 AAMI 3 ROYALSILK SURGGOWN BNS XL, Item Code 9548NC — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
2020-01-11 Class II Terminated Z-1011-2020 AAMI 3 ROYALSILK SURGGOWN BNS L, Gown. Item Code 9518NC — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
2020-01-11 Class II Terminated Z-1010-2020 AAMI 3 ROYALSILK SCRBNURGOWN BNS XL, Gown. Item Code 90380NC — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
2020-01-11 Class II Terminated Z-1009-2020 AAMI 3 ROYALSILK SCRBNURGOWN BNS L, Gown. Item Code 90280NC — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
2020-01-11 Class II Terminated Z-1008-2020 AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
2020-01-11 Class II Terminated Z-1007-2020 AAMI 3 NONREIN SCRBNURGOWN BNS XL, Gown. Item Code 90370NB — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
2020-01-11 Class II Terminated Z-1006-2020 AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
2020-01-11 Class II Terminated Z-1005-2020 AAMI 3 FABREINF SCRUB SURG GWN L NS, Gown. Item Code 90970NA — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
2020-01-11 Class II Terminated Z-1004-2020 AAMI 3 FABREINF SURG GOWN L NS, Item Code 9511NB — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
2020-01-11 Class II Terminated Z-1003-2020 AAMI 3 NON-REINF SURG GOWN 2XL BNS, Item Code 9575NB — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
2020-01-11 Class II Terminated Z-1002-2020 AAMI 3 FABRIC REINFORCEDGown 2XL NS, Item Code 9571NA — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Filings

All 510(k) clearances (2)

Date K-number Device Code Class Specialty
2022-12-20 K221603 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™ LZH Class II General Hospital
2021-11-23 K211765 Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse Gown FYA Class II General, Plastic Surgery
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence