Dover Foley catheter convenience kits recalled due to component defects
Cardinal Health is recalling Dover-branded Foley catheter convenience kits with components that were subsequently recalled by Nurse Assist. The recall affects 195,600 units distributed in the US, EMEA region, 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 medical device recall per agency classification. The rubric requires a minimum severity score of 4 (Severe) for Class I recalls regardless of reported injuries or specific hazard details.
Plain-English summary
Cardinal Health 200, LLC is recalling multiple Dover-branded Foley catheter convenience kits and associated components. These products were manufactured with components that were subsequently recalled by Nurse Assist.
The affected convenience kits include several Foley catheter variants in different sizes and configurations, along with associated drainage bags and preparation components. The recall affects 195,600 units that were distributed in the United States, EMEA region, Japan, and Latin America.
Specific lot numbers have been identified as part of this FDA Class I recall. Customers who may have been affected should check whether they have received products with the identified lot numbers and contact Cardinal Health 200, LLC for further information.
The recalled product
- Product
- 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…
- Manufacturer
- Cardinal Health 200, LLC
- Hazard
- Affected units
- 195,600
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) P4P16CSDK
- UDI/DI 20884521174068 (cs)
- 10884521174061 (ea)
- Lot Numbers: 2134218264
- 2231213064
- 2231213164
- 2231901164
- 2231901264
- 2303822464
- 2303007064
- 2307110664
- 2310808164
- 2315609464
- 2319100364
- 2319213064
- 2203300964
- 2210218464
- 2211031564
- 2213045564
- 2214449364
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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