Z-1046-2024Class I

Dover URINE METER ADD-A-FOLEY TRAY, 200 ML, NEEDLE SAMPLING PORT, DRAIN TUBE, PREP TRAY; Dover UNIVERSAL...

Name: Z-1046-2024 Dover URINE METER ADD-A-FOLEY TRAY, 200 ML, NEEDLE SAMPLING PORT, DRAIN TUBE, PREP TRAY; Dover UNIVERSAL...
Creator: Cardinal Health 200, LLC
Published: 2023-12-04
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2023-12-04 / Open, Classified / root cause: manufacturing process

FDA source

Cardinal Health 200, LLC began a recall of Dover URINE METER ADD-A-FOLEY TRAY, 200 ML, NEEDLE SAMPLING PORT, DRAIN TUBE, PREP TRAY; Dover UNIVERSAL TRAY, 1000 ML BASIN, PVP SWAB STICKS, PREPPING... on 2023-12-04. FDA classified it as Class I and gives the reason as "Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1046-2024
Classification: Class I
Status: Open, Classified
Initiated: 2023-12-04
Posted: 2024-02-16
Recalling firm: Medtronic, Inc.
Product: Dover URINE METER ADD-A-FOLEY TRAY, 200 ML, NEEDLE SAMPLING PORT, DRAIN TUBE, PREP TRAY; Dover UNIVERSAL TRAY, 1000 ML BASIN, PVP SWAB STICKS, PREPPING COMPONENTS, 30 CC PRE-FILLED SYRINGE; Dover URINE DRAINAGE ADD-A-FOLEY TRAY, NEEDLE SAMPLING, A/R, DRAIN TUBE, PREP TRAY, 30 ML SYRINGE; Dover HYDROGEL COATED LATEX FOLEY TRAY 16 FR (5.3 MM), 5 CC, 2000 ML DRAINAGE BAG, DRAIN TUBE; Dover 100% SILICONE FOLEY TRAY, NEEDLE PORT, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover 100% SILICONE FOLEY TRAY, NEEDLE PORT, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover SILICONE COATED LATEX FOLEY TRAY, 18 FR (6.0 MM), 5 CC, 2000 ML DRAINAGE BAG, DRAIN TUBE; Dover SILICONE COATED LATEX FOLEY TRAY, 16 FR (5.3 MM), 5 CC, 2000 ML DRAINAGE BAG, DRAIN TUBE; Dover HYDROGEL COATED LATEX FOLEY TRAY, LL, 18 FR (6.0 MM), 5 CC, 2000 ML BAG, DRAIN SPOUT, CSD; Dover HYDROGEL COATED LATEX FOLEY TRAY, LL, 16 FR (5.3 MM), 5 CC, 2000 ML BAG, DRAIN SPOUT, CSD; Dover 100% SILICONE FOLEY TRAY, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, CATH SECUREMENT; Dover 100% SILICONE FOLEY TRAY, LUER LOCK, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG, CATH SECUREMENT; Dover URINE METER ADD-A-FOLEY TRAY, 400 ML, TOP VENT, LUER-LOCK SAMPLING, DRAIN SPOUT, PREP TRAY; Dover 100% SILICONE SILVER-HYDROGEL COATED FOLEY TRAY, 16 FR (5.3 MM), 5 CC, 2-WAY, CATH SECUREMENT; Dover 100% SILICONE SILVER-HYDROGEL COATED FOLEY TRAY, 14 FR (4.7 MM), 5CC, 2-WAY, 2000ML DRAIN BAG; Dover 100% SILICONE FOLEY TRAY, LUER LOCK, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover HYDROGEL COATED LATEX FOLEY TRAY, NEEDLELESS, 16 FR (5.3 MM), 5 CC, 2000 ML BAG, DRAIN SPOUT; Dover 100% SILICONE FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, CATH SECUREMENT; Dover 100% SILICONE FOLEY TRAY, LUER LOCK, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover 100% SILICONE FOLEY TRAY, NEEDLE PORT, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN TUBE; Dover HYDROGEL COATED LATEX FOLEY TRAY, 16 FR (5.3 MM), 5 CC, 2000 ML DRAINAGE BAG, DRAIN SPOUT; Dover 100% SILICONE FOLEY TRAY, NEEDLELESS, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover 100% SILICONE 400 ML U/M FOLEY TRAY, LUER LOCK, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG; Dover URINE DRAINAGE ADD-A-FOLEY TRAY, NEEDLE SAMPLING, DRAIN TUBE, PREP TRAY; Dover URINE DRAINAGE ADD-A-FOLEY TRAY, NEEDLE SAMPLING, DRAIN TUBE, PREP TRAY, 30 ML LUBE SYRINGE; Dover 100% SILICONE FOLEY TRAY, NEEDLE PORT, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover HYDROGEL COATED LATEX FOLEY TRAY, 18 FR (6.0 MM), 5 CC, 2000 ML DRAINAGE BAG, DRAIN SPOUT; Dover HYDROGEL COATED LATEX FOLEY TRAY, 14 FR (4.7 MM), 5 CC, 2000 ML DRAINAGE BAG, DRAIN SPOUT; Dover HYDROGEL COATED LATEX FOLEY TRAY, LUER LOCK, 14 FR (4.7 MM), 5 CC, 2000 ML BAG, DRAIN SPOUT; Dover 100% SILICONE FOLEY TRAY, NEEDLE PORT, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN TUBE; Dover HYDROGEL COATED LATEX FOLEY TRAY, 16 FR (5.3 MM), 5 CC, 2000 ML DRAINAGE BAG, DRAIN SPOUT ; Dover HYDROGEL COATED LATEX FOLEY TRAY, 18 FR (6.0 MM), 5 CC, 2000 ML DRAINAGE BAG, DRAIN SPOUT; Dover HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, NEEDLELESS, 16 FR (5.3 MM), 5 CC, 2000 ML BAG; Dover HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LUER LOCK, 18 FR (6.0 MM), 5 CC, 2000 ML BAG; Dover 100% SILICONE 200 ML U/M FOLEY TRAY, NEEDLE PORT, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover URINE DRAINAGE ADD-A-FOLEY TRAY, NEEDLELESS SAMPLING, A/R CHAMBER, DRAIN SPOUT, PREP TRAY; Dover HYDROGEL COATED LATEX FOLEY TRAY, NEEDLELESS, 14 FR (4.7 MM), 5 CC, 2000 ML BAG, DRAIN SPOUT; Dover HYDROGEL COATED LATEX FOLEY TRAY, NEEDLELESS, 18 FR (6.0 MM), 5 CC, 2000 ML BAG, DRAIN SPOUT; Dover" 100% SILICONE FOLEY TRAY, NEEDLELESS, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover HYDROGEL COATED LATEX TRAY, LL, 14 FR (4.7 MM), 5 CC, 2000 ML BAG, DRAIN SPOUT, CSD; Dover 100% SILICONE SILVERHYDROGEL FOLEY TRAY; Dover Silicone 100% 16FR/18F; Dover 100% Silver Hydro tray
Product code: KNX Collector, Urine, (And Accessories) For Indwelling Catheter
Reason for recall: Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Cardinal Health Issued an URGENT KIT/TRAY COMPONENT RECALL NOTICE ON 12/04/2023 via FedEx next day delivery. The notice explained the issue, potential risk to health, and requested the following actions be taken: If you locate affected product within your facility, please do the following: 1. QUARANTINE affected kits/trays. 2. ALERT your clinicians of this action. 3. AFFIX the enclosed WARNING LABEL to the front of each kit/tray so that it is clearly visible to clinicians, instructing them to remove and discard the recalled component(s). 4. NOTE if you have transferred the affected kits/trays to other departments or facilities within your system, please provide a copy of this notice and recall acknowledgement form to them. 5. DISTRIBUTOR if you have further distributed affected kits/trays, please notify your customers of this recall. 6. RETURN a copy of the enclosed Acknowledgment Form confirming your receipt of this action and the completion of over labeled product via email [email protected] or fax to 614.652.9648. Additional labels will be sent to your facility upon request. For field action concerns, please contact the field action team at: [email protected] or call 800-292-9332. On 12/21/2023, Cardinal Health issued an URGENT: EXPANSION KIT/TRAY COMPONENT RECALL notice stating the following: As an update to Cardinal Healths initial communication on December 05, 2023, additional kit/trays are being included as part of the component recall. If you did not receive the initial communication on December 05, 2023, you were not impacted by the initial scope of the event. Instructions below are unchanged. Please reference Attachment 1 - Updated Impacted Products V2 for additional products impacted. The notice explained the issue, potential risk to health, and requested the same actions be taken as listed above in the 12/04/2023 letter.
Quantity in commerce: 435060 units
Distribution: US and EMEA, Japan, Latin America
Product codes and lots: a) 6140, 30884521015214 (cs), 10884521015210 (ea), UDI/DI Lot Numbers: 2206723264, 2310813264, 2213047664, 2213301264, 2211624264 2205319164, 2209519564, 2218504964; b) 6148LL, UDI/DI 30884521015528 (cs), 10884521015524 (ea), Lot Numbers: 2210903364, 2308701264, 2310107364, 2212900264, 2212900364; c) 6153, UDI/DI 30884521015252 (cs), 10884521015258 (ea), Lot Numbers: 2206007764, 2222830664, 2233605264, 2300125764, 2300125864, 2300132664, 2314302964, 2205201164, 2206007864, 2213047864, 2223545264, 2304402364, 2317731064, 2211628564, 2205329464, 2205328764, 2213742064, 2216533964; d) 6154, UDI/DI 20884521015262 (cs), 10884521015265 (ea), Lot Numbers: 2233605364, 2206011164, 2309042764, 2217922664; e) 8949, UDI/DI 30884521015399 (cs), 10884521015395 (ea), Lot Numbers: 2206903964, 2206904064, 2313507764, 2313507864, 2322322564, 2223546964, 2306613764, 2205201264, 2310108164, 2205320964, 2209526764; f) PP14SD, UDI/DI 20884521029672 (cs), 10884521029675 (ea), Lot Numbers: 2301030764, 2216500164, 2309039464, 2314220064, 2203931264, 2317729764, 2200119164, 2200427964, 2201132564, 2215117664; g) PP16SD, UDI/DI 20884521029696 (cs), 10884521029699 (ea), Lot Numbers: 2213738864, 2313806164, 2321617264, 2303818764, 2304400164, 2301023064, 2301023164, 2307110464, 2308004064, 2310901664, 2310901864, 2314306964, 2318416964, 2319218264, 2203928664, 2210901564, 2209524064, 2216500264, 2216533864, 2304400264, 2302000364, 2302401364, 2302401464, 2313100464, 2313806064, 2215111764, 2215111864, 2216801464, 2305903064, 2134217964, 2200119064, 2200428064, 2201132664, 2204633564, 2204633664, 2208814464, 2215823864; h) PP18SD, UDI/DI 20884521029719 (cs), 10884521029712 (ea), Lot Numbers: 2303822164, 2310807864, 2212321464, 2317729964, 2203931364 i) 3718, Lot Numbers: 2303815264, 2307202164, 2209534664, 2223544564, 2219402664, 2220726564, 2206727764, 2201131264, 2203933064, 2209525464, 2210232964, 2217921964 j) 3716, 2203930364, 2206718464, 2213046664, 2222114064, 2222114164, 2222830064, 2303815064, 2303815164, 2308002764, 2307109164, 2307109264, 2308002564, 2314901264, 2314901364, 2206718364, 2209530364, 2214452164, 2215825964, 2218612564, 2304401864, 2304701764, 2305203064, 2308002664, 2308700864, 2308719164, 2211621264, 2211621364, 2210900964, 2210901064, 2216502664, 2310107164, 2207404064, 2310301864, 2200120364, 2200120464, 2200429564, 2200429664, 2203930464, 2203930564, 2204635764, 2204635864, 2205317964, 2205318064, 2206024964, 2206025064, 2208812264, 2209101864, 2212301864, 2212301964, 2216806264, 2217921864 k) PP18ULD, Lot Numbers: 2215117764, 2312205864 l) PP16ULD, Lot Numbers: 2209514764, 2209514864, 2214449264, 2217919664, 2308700364, 2311521264, 2317729864, 2313805964, 2322321364, 2208814564, 2215823964 n) 8324, Lot Number: 2210221064 o) 7020LL, Lot Numbers: 2303824064, 2210220864, 2223546364, 2232613764, 2312912164, 2209526064, 2215826864 p) 6080, Lot Number: 2214452564 q) PP16XSD, Lot Numbers: 2301030964, 2204633764, 2207402364, 2219310764, 2302405264, 2312205764, 2217919764 r) 6144ICLL, UDI/DI 30884521009121 (cs), 10884521009127 (ea) Lot Numbers: 2216802364, 2208800564, 2307111564 s) 6148LL, Lot Numbers: 2210903364, 2308701264, 2310107364, 2212900264, 2212900364 t) 6155, Lot Numbers: 2205319564, 2205328664, 2216802264, 2318417664, 2213047964, 2312208664, 2312208864, 2313100564, 2313100664, 2210903464, 2310107464 u) 3532, Lot Numbers: 2213741364, 2306612564, 2314901664 v) 6014, Lot Numbers: 2211030964, 2308700964, 2309042564, 2308900664, 2216806564, 2205318964, 2215119764

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1046-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1043-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-02-28	2024-02-16
Z-1044-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-02-28	2024-02-16
Z-1045-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-02-28	2024-02-16
Z-1046-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-02-28	2024-02-16
Z-1047-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-02-28	2024-02-16
Z-1048-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-02-28	2024-02-16
Z-1049-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-02-28	2024-02-16
Z-1050-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-02-28	2024-02-16
Z-1051-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-02-28	2024-02-16
Z-1052-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-02-28	2024-02-16

Product code KNX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)