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U.S. Department of Health and Human Services

Class 1 Device Recall Cardinal Health COVIDIEN Dover

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  Class 1 Device Recall Cardinal Health COVIDIEN Dover see related information
Date Initiated by Firm December 04, 2023
Date Posted February 16, 2024
Recall Status1 Open3, Classified
Recall Number Z-1046-2024
Recall Event ID 93551
Product Classification Collector, urine, (and accessories) for indwelling catheter - Product Code KNX
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
Code Information 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
Recalling Firm/
Manufacturer		 Cardinal Health 200, LLC
3651 Birchwood Dr
Waukegan IL 60085-8337
For Additional Information Contact
847-887-5500
Manufacturer Reason
for Recall		 Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
FDA Determined
Cause 2		 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 GMB-FieldCorrectiveAction@cardinalhealth.com 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: GMB-FieldCorrectiveAction@cardinalhealth.com 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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