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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices

Cardinal Health 200, LLC: Medical Convenience Kits Recalled Due to Compromised Component Sterility

Agency Publication Date: February 16, 2024
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Summary

Approximately 1,448,760 Cardinal Health convenience kits, including Argyle suction catheters, Dover Foley trays, and tracheostomy kits, are being recalled because they contain components (such as sterile saline or water) previously recalled by Nurse Assist. These kits were distributed in the US and globally between December 2021 and late 2023. The recall was initiated because the sterility of the included Nurse Assist components cannot be guaranteed, which may lead to serious infections in patients using these medical devices.

Risk

If the components are not sterile, they may contain bacteria that cause life-threatening infections, especially in patients with weakened immune systems or those undergoing invasive procedures. Cardinal Health has identified these products as critical risk items because the affected saline or water is used in direct contact with sensitive areas like the airway or urinary tract.

What You Should Do

  1. Identify your product by checking the packaging for the brand names Argyle or Dover, and looking for specific REF numbers such as 10082, 47802, 6140, 7946, or 1814 among many others listed in the product details.
  2. Check the lot numbers on your device packaging against the affected list, including numbers like 2216804164, 2305711364, 2313507764, and 2312206964; note that many affected lot numbers end in '64'.
  3. Immediately stop using any affected kits found in your inventory and quarantine the products to prevent accidental use.
  4. Contact your healthcare provider if you have used one of these kits and have concerns about infection or other health complications.
  5. Contact Cardinal Health directly at their Waukegan, Illinois location or through their clinical support channels for further instructions on returning or disposing of the affected kits.
  6. For additional questions or to report a problem, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

📋Other Action

Quarantine and return or disposal

How to: Contact your healthcare provider or the manufacturer (Cardinal Health) for further instructions and potential credit or refund.

Affected Products

Product: Argyle Suction Catheter Tray with Chimney Valve (Multiple Sizes/Sterile Saline)
Model / REF:
REF 10082
REF 12062
REF 12082
REF 12182
REF 12102
REF 12153
REF 12142
REF 10122
REF 10142
REF 10102
REF 12191
UPC Codes:
50192253041673
10192253041675
50192253041710
10192253041712
50192253041680
10192253041682
50192253041697
10192253041699
50192253041642
10192253041644
50192253041628
10192253041620
50192253041727
10192253041729
Lot Numbers (98):
2216804164
2219915464
2203926164
2206715364
2207413264
2219915564
2201820964
2205203064
230381696
2221306664
2222135264
2306633164
2200301264
2201821064
2215804564
2206715464
2210203464
2303107164
2200423964
2203505264
2204604164
2219905464
2220700264
2221306564
2234028964
2234029064
2301204364
2234029764
2234729464
2234729564
2302409864
2302419564
2308901764
2324809964
2135114264
2227022264
2302419564
2311517164
2200423864
2204604064
2208105864
2211605564
2209404264
2210203564
2213010564
2215804664
2216804464
2219905364
2220700164
2221306464
Product: TRACH KIT W/HYDROGEN & SALI
Model / REF:
REF 47802
Lot Numbers (64):
2201103364
2201103464
2201804164
2201804264
2204627064
2204627364
2204801164
2205309664
2205309764
2206020664
2206020764
2206731664
2206731764
2208117464
2208117564
2208828064
2208828164
2212326364
2213014664
2215107664
2215808564
2222816264
2216523964
2217209464
2219323864
2217915264
2219326264
2219910964
2221312264
2221312164
2222816164
2222816364
2223528364
2223528464
2224243164
2224243264
2224929764
2224929864
2225515664
2226320664
2225515764
2226320764
2227034464
2229112364
2227725164
2227725264
2227022264
2231226564
2231914264
2305711364
Product: Dover 100% Silicone/Hydrogel Foley Trays (Various Models)
Model / REF:
REF 6256
REF 6175
REF 2018
REF 76020
REF 76000
REF 5027
REF 3044
REF 2101
REF 5029
REF 2006
REF 2016
REF 76030
REF 76010
REF 76012
UPC Codes:
30884521003389
10884521003385
30884521003396
10884521003392
Lot Numbers (89):
2301032164
2206016464
2210904964
2218622964
2225305364
2305232064
2217924364
2209525764
2205319864
2205328564
2205334664
2209408564
2210208264
2211007864
2211610264
2215109464
2222808464
2220707664
2220726364
2223515264
2224800564
2307904064
2315710664
2316409064
2209408264
2210207964
2211007564
2213709364
2214416164
2211609964
2215109364
2216525364
2215809864
2217211464
2217912564
2220901064
2303825364
2304507464
2305228764
2305228964
2305706764
2312920964
2321910264
2308203564
2313507264
2314219064
2214434964
2214435064
2225305264
2227031164
Product: Dover Urine Meter/Drainage Add-A-Foley Tray & Trays
Model / REF:
6140
6148LL
6153
6154
8949
PP14SD
PP16SD
PP18SD
3718
3716
PP18ULD
PP16ULD
8324
7020LL
6080
PP16XSD
6144ICLL
6155
3532
6014
UPC Codes:
30884521015214
10884521015210
30884521015528
10884521015524
30884521015252
10884521015258
20884521015262
10884521015265
30884521015399
10884521015395
20884521029672
10884521029675
20884521029696
10884521029699
20884521029719
10884521029712
30884521009121
10884521009127
Lot Numbers (214):
2206723264
2310813264
2213047664
2213301264
2211624264
2205319164
2209519564
2218504964
2210903364
2308701264
2310107364
2212900264
2212900364
2206007764
2222830664
2233605264
2300125764
2300125864
2300132664
2314302964
2205201164
2206007864
2213047864
2223545264
2304402364
2317731064
2211628564
2205329464
2205328764
2213742064
2216533964
2233605364
2206011164
2309042764
2217922664
2206903964
2206904064
2313507764
2313507864
2322322564
2223546964
2306613764
2205201264
2310108164
2205320964
2209526764
2301030764
2216500164
2309039464
2314220064
Product: Dover Hydrogel Coated Latex/100% Silicone Temp Sense Foley Trays
Model / REF:
P4P14TSD
P4P16XTSD
P4P18XTSD
P4P18TS
P4P16XTS
P4P16TS
P4P16ULD
P4P14SD
P4P18XSD
P4P16XSD
P4P16SD
UPC Codes:
20884521066950
10884521066953
Lot Numbers (124):
2210218264
2319101064
2304400564
2216804964
2204636464
2304400764
2214449464
2303011464
2319902164
2305206364
2313614664
2322605064
2213739364
2306628864
2217920364
2219401064
2210218864
2203931464
2208814964
2217920264
2219400964
2206726264
2213739064
2222821064
2222821164
2206013564
2223543364
2134218364
2308007664
2315604264
2301703664
2210218664
2208814764
2212321764
2206725964
2310807964
2315604664
2204636264
2210901764
2216500364
2209524164
2215824064
2217919864
2231220364
2310808464
2204636764
2206013664
2303011364
2322321564
2231220164
Product: Dover 100% Silicone Coudé Tip/Hydrogel Foley Trays & Irrigation Tray
Model / REF:
P4P16CSDK
P4P18CSDK
66820
6146LL
P4P16CSD
7006ICLL
7006LL
7946
1814
UPC Codes:
20884521174068
10884521174061
20884521174075
20884521174078
30884521015504
10884521015500
20884521143347
10884521143340
20884521029559
10884521029552
20884521003528
10884521003521
Lot Numbers (124):
2134218264
2231213064
2231213164
2231901164
2231901264
2303822464
2303007064
2307110664
2310808164
2315609464
2319100364
2319213064
2203300964
2210218464
2211031564
2213045564
2214449364
2215824164
2216500464
2217920064
2219400664
2300202064
2304400364
2304400464
2301703364
2303006964
2308700564
2309041264
2312206464
2321324164
2322006864
2211626864
2305206264
2322102764
2206726164
2216805064
2313615064
2313614964
2312908364
2201151164
2201201664
2202401464
2200603564
2205315264
2209524264
2213738964
2215117864
2231213564
2308004464
2319100564

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93551
Status: Active
Manufacturer: Cardinal Health 200, LLC
Sold By: Cardinal Health authorized distributors; Hospitals; Medical clinics; Specialty retailers
Manufactured In: United States
Units Affected: 10 products (25896 units; 661,560 units; 17640 units; 435060 units; 7800 units; 195600 units; 63360 units; 4620 units; 36300 units; 924 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release (1) · FDA Press Release (2) · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.