Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Dover" 100% SILICONE 400 ML U/M FOLEY TRAY Recalled by Cardinal Health 200, LLC Due to Convenience kits were manufactured and distributed with components...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Cardinal Health 200, LLC directly.
Affected Products
Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HYDROGEL COATED LATEX FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML BAG, DRAIN SPOUT; Dover" URINE DRAINAGE ADD-A-FOLEY TRAY, LUER LOCK SAMPLING PORT, A/R DEVICE, DRAIN SPOUT, PREP TRAY; Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML BAG; Dover" UNIVERSAL TRAY, 1000 ML BASIN, BZK SWAB STICKS, PREPPING COMPONENTS, 10 ML PRE-FILLED SYRINGE; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400ML U/M FOLEY TRAY, COUD¿ TIP, 16FR (5.3 MM), 5CC; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG (2-person); Dover" 100% SILICONE SILVER-HYDROGEL COATED 400ML U/M FOLEY TRAY, COUD¿ TIP, 18FR (6.0 MM), 5CC; Dover" PREMIUM URINE DRAINAGE ADD-A-FOLEY TRAY, LUER-LOCK, DRAIN SPOUT, CATHETER SECUREMENT DEVICE
Quantity: 195600 units
Why Was This Recalled?
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
Where Was This Sold?
US and EMEA, Japan, Latin America
About Cardinal Health 200, LLC
Cardinal Health 200, LLC has 275 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report