Dover Foley catheters recalled due to defective supplied components
Cardinal Health Dover Foley catheters (7,800 units distributed in the US, EMEA, Japan, and Latin America) are being recalled because convenience kits were manufactured with components previously recalled by Nurse Assist.
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 score of 4. Though the source does not specify the nature of the component defect or report confirmed incidents, the Class I designation indicates potential for serious injury.
Plain-English summary
Cardinal Health is recalling Dover brand Foley catheters that were distributed in convenience kits. These kits contained approximately 7,800 units across multiple product variants, including silicone and latex catheters in various sizes (14 FR, 16 FR, and 18 FR) with optional hydrogel or silver-hydrogel coatings, temperature sensing capabilities, and drainage bags.
The convenience kits were manufactured and distributed with components that had been previously recalled by Nurse Assist. This secondary recall was initiated after the component defect was identified.
The affected products were distributed to the United States, EMEA region (Europe, Middle East, and Africa), Japan, and Latin America. Specific lot numbers and product codes have been documented in the FDA recall notice.
Customers in possession of these products should verify their lot numbers against the FDA's published list. Contact Cardinal Health or your healthcare supplier for guidance on whether your inventory is affected and appropriate next steps.
The recalled product
- Product
- Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LL, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, CSD; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400ML U/M TEMP SENSE FOLEY TRAY, 16FR (5.3 MM), 5CC, CSD; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400ML U/M TEMP SENSE FOLEY…
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Foley Catheters
- Hazard
- Affected units
- 7,800
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)
- P4P14TSD
- UDI/DI 20884521066950 (cs)
- 10884521066953 (ea) Lot Numbers: 2210218264
- 2319101064
- 2304400564
- 2216804964 P4P16XTSD
- Lot Numbers: 2204636464
- 2304400764
- 2214449464
- 2303011464
- 2319902164
- 2305206364
- 2313614664
- 2322605064 P4P18XTSD
- Lot Numbers: 2213739364
- 2306628864
- 2217920364 P4P14TSD
- Lot Numbers: 2210218264
- 2216804964 P4P18TS
- Lot Numbers: 2219401064
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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