Dover Foley catheter kits recalled due to defective supplier components
Cardinal Health is recalling Dover brand Foley catheter kits due to components recalled by supplier Nurse Assist. Approximately 435,060 units were distributed to the US, Europe, 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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: FDA Class I classification indicates serious health hazard and potential for serious injury or death, per recall severity criteria.
Plain-English summary
Cardinal Health 200, LLC is recalling multiple Dover brand Foley catheter and urinary drainage kits. The kits were distributed with components that were subsequently recalled by Nurse Assist, the component supplier.
Approximately 435,060 units in various configurations were distributed to the United States, EMEA region, Japan, and Latin America. Affected products include different catheter sizes, materials (silicone, latex, and coated variants), and drainage capacities.
This is an FDA Class I recall. Healthcare providers and patients should consult their healthcare provider regarding use of affected kits and available alternatives. Specific lot numbers and UDI codes for affected products are available from the FDA.
The recalled product
- Product
- Dover URINE METER ADD-A-FOLEY TRAY, 200 ML, NEEDLE SAMPLING PORT, DRAIN TUBE, PREP TRAY; Dover UNIVERSAL TRAY, 1000 ML BASIN, PVP SWAB STICKS, PREPPING COMPONENTS, 30 CC PRE-FILLED SYRINGE; Dover URINE DRAINAGE ADD-A-FOLEY TRAY, NEEDLE SAMPLING, A/R, DRAIN TUBE, PREP TRAY, 30 ML…
- Manufacturer
- Cardinal Health 200, LLC
- Hazard
- Affected units
- 435,060
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) 6140
- 30884521015214 (cs)
- 10884521015210 (ea)
- UDI/DI Lot Numbers: 2206723264
- 2310813264
- 2213047664
- 2213301264
- 2211624264 2205319164
- 2209519564
- 2218504964
- b) 6148LL
- UDI/DI 30884521015528 (cs)
- 10884521015524 (ea)
- Lot Numbers: 2210903364
- 2308701264
- 2310107364
- 2212900264
- 2212900364
- c) 6153
- UDI/DI 30884521015252 (cs)
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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