Reported Feb 28, 2024 · Ongoing
Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, NEEDLE PORT, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HYDROGEL…
Cardinal Health 200, LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cardinal Health 200, LLC · 3651 Birchwood Dr · Waukegan, IL · 60085-8337
Is this the product you have?
21 of 21 products
| # | Product as published |
|---|---|
| 1 | Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, NEEDLE PORT, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG |
| 2 | Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, NEEDLE, 16 FR (5.3 MM), 5 CC, 2000 ML BAG |
| 3 | Dover" UNIVERSAL TRAY, 1000 ML BASIN, PVP SOLUTION, PREPPING COMPONENTS, 10 ML PRE-FILLED SYRINGE |
| 4 | Dover" UNIVERSAL TRAY, 1000 ML BASIN, BZK SWAB STICKS, PREPPING COMPONENTS, 10 ML PRE-FILLED SYRINGE |
| 5 | Dover" UNIVERSAL TRAY, 1000 ML BASIN, PVP SWAB STICKS, PREPPING COMPONENTS, 10 ML PRE-FILLED SYRINGE |
| 6 | Dover" UNIVERSAL TRAY, 1200 ML BASIN, PVP SWAB STICKS, PREPPING COMPONENTS, 10 CC PRE-FILLED SYRINGE |
| 7 | Dover" 100% SILICONE FOLEY INSERTION TRAY, 18 FR (6.0 MM), 5 CC, PREP TRAY |
| 8 | Dover" HYDROGEL COATED LATEX FOLEY INSERTION TRAY, 18 FR (6.0 MM), 5 CC, PREP TRAY |
| 9 | Dover" HYDROGEL COATED LATEX FOLEY INSERTION TRAY, 16 FR (5.3 MM), 5 CC, PREP TRAY |
| 10 | Dover" UNIVERSAL TRAY, 1000 ML BASIN, PVP SOLUTION, PREPPING COMPONENTS, 10 CC PRE-FILLED SYRINGE |
| 11 | Dover" 100% SILICONE FOLEY INSERTION TRAY, 16 FR (5.3 MM), 5 CC, PREP TRAY |
| 12 | Dover" URINE DRAINAGE ADD-A-FOLEY TRAY, NEEDLE SAMPLING, DRAIN TUBE, PREP TRAY |
| 13 | Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, NEEDLE, 18 FR (6.0 MM), 5 CC, 2000 ML BAG |
| 14 | Dover" UNIVERSAL TRAY, 1000 ML BASIN, BZK SWAB STICKS, PREPPING COMPONENTS, 30 CC PRE-FILLED SYRINGE |
| 15 | Dover" UNIVERSAL TRAY, 1000 ML BASIN, PVP SOLUTION, PREPPING COMPONENTS, 30 CC PRE-FILLED SYRINGE |
| 16 | Dover" URINE METER ADD-A-FOLEY TRAY, 400 ML, NEEDLE SAMPLING, DRAIN SPOUT, PREP TRAY |
| 17 | Dover" SILICONE ELASTOMER COATED LATEX FOLEY TRAY, 16 FR (5.3 MM), 5 CC, 2000 ML DRAINAGE BAG |
| 18 | Dover" 100% SILICONE FOLEY CATHETER KIT, 5 CC, 2-WAY, 16 FR (5.3 MM), LUBE, STRL WATER, 10CC SYRINGE |
| 19 | Dover" URINE DRAINAGE ADD-A-FOLEY TRAY, NEEDLE SAMPLING, DRAIN TUBE, PREP TRAY |
| 20 | Dover" URINE DRAINAGE ADD-A-FOLEY TRAY, NEEDLE SAMPLING, A/R CHAMBER, DRAIN SPOUT, PREP TRAY |
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Barcodes Product as published 502730884521003389108845210033858887600776, 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 , Lot Numbers:2214434964, 2214435064, 2225305264, 2227031164, 2301018164, 2305904064, 2319902764 201630884521003396108845210033928887600784, 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 , Lot Numbers: 2205334564, 2215118364 760128887601220, 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 , Lot Numbers: 2132134964, 2208109164, 2211007764, 2210208164, 2209408464 - Amount recalled
- 17640 units
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Why it was recalled
Stop using this product now
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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