Cardinal Health 200, LLC: Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LL, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, CSD; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400ML U/M TEMP SENSE FOLEY TRAY, 16FR (5.3 MM), 5CC, CSD; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400ML U/M TEMP SENSE FOLEY TRAY, 18FR (6.0 MM), 5CC, CSD; Dover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 14 FR (4.7 MM), 5CC, 2000ML DRAIN BAG, CSD; Dover" 100% SILICONE 400 ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400 ML U/M TEMP SENSE FOLEY TRAY, 16 FR (5.3 MM), 5 CC; Dover" 100% SILICONE 400 ML U/M TEMP SENSE FOLEY TRAY, LL, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LL, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, CSD; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, LL, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, CATH SECURE; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400 ML U/M FOLEY TRAY, 18 FR (6.0 MM), 5 CC, CATH SECURE; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400 ML U/M FOLEY TRAY, 16 FR (5.3 MM), 5 CC, CATH SECURE; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, LL, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, CATH SECURE; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400 ML U/M FOLEY TRAY, 14 FR (4.7 MM), 5 CC, CATH SECURE; Dover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 16 FR (5.3 MM), 5CC, 2000ML DRAIN BAG, CSD; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, LL, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG, CATH SECURE; Dover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR (6.0 MM), 5CC, 2000ML DRAIN BAG, CSD

Recall number

Z-1047-2024

Recalling firm

Cardinal Health 200, LLC

Product

Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LL, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, CSD; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400ML U/M TEMP SENSE FOLEY TRAY, 16FR (5.3 MM), 5CC, CSD; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400ML U/M TEMP SENSE FOLEY TRAY, 18FR (6.0 MM), 5CC, CSD; Dover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 14 FR (4.7 MM), 5CC, 2000ML DRAIN BAG, CSD; Dover" 100% SILICONE 400 ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400 ML U/M TEMP SENSE FOLEY TRAY, 16 FR (5.3 MM), 5 CC; Dover" 100% SILICONE 400 ML U/M TEMP SENSE FOLEY TRAY, LL, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LL, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, CSD; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, LL, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, CATH SECURE; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400 ML U/M FOLEY TRAY, 18 FR (6.0 MM), 5 CC, CATH SECURE; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400 ML U/M FOLEY TRAY, 16 FR (5.3 MM), 5 CC, CATH SECURE; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, LL, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, CATH SECURE; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400 ML U/M FOLEY TRAY, 14 FR (4.7 MM), 5 CC, CATH SECURE; Dover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 16 FR (5.3 MM), 5CC, 2000ML DRAIN BAG, CSD; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, LL, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG, CATH SECURE; Dover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR (6.0 MM), 5CC, 2000ML DRAIN BAG, CSD

Status

Open, Classified

Initiated

2023-12-04

Posted

2024-02-16

Terminated

not on file

Reason

Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.

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 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

7800 units

Distribution

US and EMEA, Japan, Latin America

Lot, serial or model codes

P4P14TSD, UDI/DI 20884521066950 (cs), 10884521066953 (ea) Lot Numbers: 2210218264, 2319101064, 2304400564, 2216804964 P4P16XTSD, Lot Numbers: 2204636464, 2304400764, 2214449464, 2303011464, 2319902164, 2305206364, 2313614664, 2322605064 P4P18XTSD, Lot Numbers: 2213739364, 2306628864, 2217920364 P4P14TSD, Lot Numbers: 2210218264, 2319101064, 2304400564, 2216804964 P4P18TS, Lot Numbers: 2219401064, 2210218864 P4P16XTS, Lot Numbers: 2203931464, 2208814964, 2217920264, 2219400964 P4P16TS, Lot Numbers: 2206726264, 2213739064, 2222821064, 2222821164, 2206013564, 2223543364, 2134218364 P4P16ULD, Lot Numbers: 2308007664, 2315604264, 2301703664, 2210218664, 2208814764, 2212321764 P4P14SD, Lot Numbers: 2206725964, 2310807964, 2315604664, 2204636264, 2210901764, 2216500364, 2209524164, 2215824064, 2217919864 P4P18XSD, Lot Numbers: 2231220364, 2310808464, 2204636764 P4P16XSD, Lot Numbers: 2206013664, 2303011364, 2322321564, 2231220164, 2300202364, 2308702164, 2310808264, 2315604164, 2215100464, 2301703764, 2312206864, 2305403964, 2205315564, 2207402864, 2208814864, 2215117964, 2215301864 P4P16SD, Lot Numbers: 2303820764, 2303820864, 2304400664, 2303820664, 2307107964, 2308007864, 2311120164, 2312302264, 2315604364, 2317003864, 2317003964, 2203928364, 2206013464, 2210901964, 2211626964, 2213042864, 2213042964, 2213043064, 2219400764, 2232517664, 2300202164, 2305201964, 2305202064, 2301703464, 2312206664, 2312908564, 2312908664, 2319902064, 2321318164, 2321318264, 2211801264, 2216807664, 2216802864, 2216802764, 2305232164, 2305900264, 2305900364, 2322102964, 2313614864, 2310212764, 2201116464, 2134203264, 2134203364, 2200118864, 2200118964, 2200428164, 2203928464, 2204633964, 2204634064, 2205315364, 2207402764, 2210218564, 2208814664, 2212321664, 2212500164, 2214422064, 2214422164, 2217917064, 2217917164, 2218625764, 2201116564

510(k) numbers

not on file

PMA numbers

not on file

Product code

FFG

Firm FEI

3001236905

Firm city

Waukegan

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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