Dover Foley Catheter and Urinary Drainage Kits Recalled for Defective Components
Cardinal Health is recalling Dover foley catheter and urinary drainage kits containing components previously recalled by supplier Nurse Assist. The FDA Class I recall affects 17,640 units distributed to the US, EMEA, Japan, and Latin America.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification requires a minimum severity rating of Severe (4). No deaths, illnesses, or injuries have been reported in the source material. The FDA Class I designation reflects the potential risk inherent in medical devices with component integrity issues.
Plain-English summary
Cardinal Health 200, LLC is recalling multiple Dover brand foley catheter and urinary drainage convenience kits. The recalled products include 100% silicone foley trays, hydrogel-coated latex foley trays, universal urine collection kits, and related urological devices in various configurations. These convenience kits were manufactured with components that were subsequently recalled by Nurse Assist, the original supplier of those components.
The FDA has classified this as a Class I recall. The recall affects 17,640 units that were distributed to the United States, EMEA (Europe, Middle East, Africa), Japan, and Latin America. Specific product reference numbers and lot numbers associated with the recalled units are available from Cardinal Health or the FDA.
Healthcare facilities and medical suppliers in the affected regions should verify their inventory against the specific lot numbers and product reference codes provided by Cardinal Health or the FDA to determine if they received affected units. Customers are advised to contact Cardinal Health directly for instructions regarding the recalled products.
The recalled product
- 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…
- Manufacturer
- Cardinal Health 200, LLC
- Hazard
- Affected units
- 17,640
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 10 recalled by Cardinal Health 200, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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