--- title: "Dover\" 100% SILICONE 400 ML U/M FOLEY TRAY, NEEDLE PORT, 16 FR (5.3 MM), 5 CC... — FDA record Z-1045-2024 | Is It on Recall" description: "Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist." url: https://isitonrecall.com/recall/fda-device-z-1045-2024-dover-100-silicone-400-ml-u-m-foley-tray-needle-port-16-fr-5-3-mm-5-cc-2000-ml-drain-bag-dover-hydro/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, NEEDLE PORT, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HYDROGEL COA... — FDA record Z-1045-2024 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Dec 4, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, NEEDLE PORT, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, NEEDLE, 16 FR (5.3 MM), 5 CC, 2000 ML BAG; Dover" UNIVERSAL TRAY, 1000 ML BASIN, PVP SOLUTION, PREPPING COMPONENTS, 10 ML PRE-FILLED SYRINGE; Dover" UNIVERSAL TRAY, 1000 ML BASIN, BZK SWAB STICKS, PREPPING COMPONENTS, 10 ML PRE-FILLED SYRINGE; Dover" UNIVERSAL TRAY, 1000 ML BASIN, PVP SWAB STICKS, PREPPING COMPONENTS, 10 ML PRE-FILLED SYRINGE; Dover" UNIVERSAL TRAY, 1200 ML BASIN, PVP SWAB STICKS, PREPPING COMPONENTS, 10 CC PRE-FILLED SYRINGE; Dover" 100% SILICONE FOLEY INSERTION TRAY, 18 FR (6.0 MM), 5 CC, PREP TRAY; Dover" HYDROGEL COATED LATEX FOLEY INSERTION TRAY, 18 FR (6.0 MM), 5 CC, PREP TRAY; Dover" HYDROGEL COATED LATEX FOLEY INSERTION TRAY, 16 FR (5.3 MM), 5 CC, PREP TRAY; Dover" UNIVERSAL TRAY, 1000 ML BASIN, PVP SOLUTION, PREPPING COMPONENTS, 10 CC PRE-FILLED SYRINGE; Dover" 100% SILICONE FOLEY INSERTION TRAY, 16 FR (5.3 MM), 5 CC, PREP TRAY; Dover" URINE DRAINAGE ADD-A-FOLEY TRAY, NEEDLE SAMPLING, DRAIN TUBE, PREP TRAY; Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, NEEDLE, 18 FR (6.0 MM), 5 CC, 2000 ML BAG; Dover" UNIVERSAL TRAY, 1000 ML BASIN, BZK SWAB STICKS, PREPPING COMPONENTS, 30 CC PRE-FILLED SYRINGE; Dover" UNIVERSAL TRAY, 1000 ML BASIN, PVP SOLUTION, PREPPING COMPONENTS, 30 CC PRE-FILLED SYRINGE; Dover" URINE METER ADD-A-FOLEY TRAY, 400 ML, NEEDLE SAMPLING, DRAIN SPOUT, PREP TRAY; Dover" SILICONE ELASTOMER COATED LATEX FOLEY TRAY, 16 FR (5.3 MM), 5 CC, 2000 ML DRAINAGE BAG; Dover" 100% SILICONE FOLEY CATHETER KIT, 5 CC, 2-WAY, 16 FR (5.3 MM), LUBE, STRL WATER, 10CC SYRINGE; Dover" URINE DRAINAGE ADD-A-FOLEY TRAY, NEEDLE SAMPLING, DRAIN TUBE, PREP TRAY; Dover" URINE DRAINAGE ADD-A-FOLEY TRAY, NEEDLE SAMPLING, A/R CHAMBER, DRAIN SPOUT, PREP TRAY; Dover" UNIVERSAL TRAY, 1000 ML BASIN, PVP SWAB STICKS, PREPPING COMPONENTS, 30 CC PRE-FILLED SYRINGE - **Reason**: Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist. - **Classification**: Class I - **Recalling firm**: Cardinal Health 200, LLC - **Quantity**: 17640 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-1045-2024 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1045-2024%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | a) 8887600776, UDI/DI 30884521003389 (cs), 10884521003385 (ea), Lot Numbers: 2301032164, 2206016464, 2210904964, 2218622964, 2225305364, 2305232064, 2217924364. REF 6256, Lot Number: 2209525764 REF 6175, Lot Numbers: 2205319864, 2205328564 REF 2018, Lot Numbers: 2205334664 REF 76020, Lot Numbers: 2209408564, 2210208264, 2211007864, 2211610264, 2215109464, 2222808464, 2220707664, 2220726364, 2223515264, 2224800564, 2307904064, 2315710664, 2316409064 REF 76000, Lot Numbers: 2209408264, 2210207964, 2211007564, 2213709364, 2214416164, 2211609964, 2215109364, 2216525364, 2215809864, 2217211464, 2217912564, 2220901064, 2303825364, 2304507464, 2305228764, 2305228964, 2305706764, 2312920964, 2321910264, 2308203564, 2313507264, 2314219064 REF 5027, Lot Numbers:2214434964, 2214435064, 2225305264, 2227031164, 2301018164, 2305904064, 2319902764 b) 8887600784, UDI/DI 30884521003396 (cs), 10884521003392 (ea), Lot Numbers: 2215120764, 2215827464. REF 3044, Lot Number: 2208815964. REF 2101, Lot Numbers: 2214422964, 2214423064 REF 5029, Lot Numbers: 2204637764, 2208812764, 2208812864, 2217922164 REF 2006, Lot Numbers: 2215118264 REF 2016, Lot Numbers: 2205334564, 2215118364 c) 8887601220, Lot Numbers: 2208901164, 2216807564 REF 76030, Lot Numbers: 2134208364, 2208109364, 2215109564, 2209408664, 2210208364 REF 76010, Lot Numbers: 2132716964, 2132717064, 2133422864, 2133422964, 2134110464, 2134110564, 2208109064, 2211007664, 2211610064, 2212328664, 209408364, 2210208064 REF 76012, Lot Numbers: 2132134964, 2208109164, 2211007764, 2210208164, 2209408464 | Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution US and EMEA, Japan, Latin America No US distribution state could be established from this record. Check the official notice. ## Dates in the source - **Report date**: Feb 28, 2024 - **Recall initiation date**: Dec 4, 2023 - **Center classification date**: Feb 16, 2024 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1045-2024%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Cardinal Health 200, LLC records](https://isitonrecall.com/brand/cardinal-health-200-llc/)