Cardinal Health Foley Catheter Kits Recalled Over Supplier Component Defect
Cardinal Health is recalling 36,300 Foley urinary drainage convenience kits due to components that were subsequently recalled by supplier 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 rating of Severe. Although no deaths or serious injuries have been reported, the agency's own classification as Class I establishes this recall at Severe level per regulatory standards.
Plain-English summary
Cardinal Health 200, LLC is recalling 36,300 units of Dover 100% Silicone Foley catheter trays combined with 2000ML drain bags. These medical convenience kits contain components that were recalled by Nurse Assist, the component supplier. The affected product is an 18 FR catheter with 5CC balloon capacity.
The kits were distributed to customers in the United States, European Union/Middle Eastern/African regions (EMEA), Japan, and Latin America. The recall affects multiple lot numbers: 2222832064, 2301031864, 2317001864, 2209526164, 2215827064, 2317731864, 2305204964, 2305205064, 2210226764, and 2208817764.
Healthcare providers and customers who have received these kits should cease use and contact their supplier or Cardinal Health for instructions on replacement or return of the affected product.
The recalled product
- Product
- Dover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR (6.0 MM), 5CC, 2000ML DRAIN BAG, CSD
- Manufacturer
- Cardinal Health 200, LLC
- Hazard
- Affected units
- 36,300
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 (13)
- 7946
- UDI/DI 20884521029559 (cs)
- 10884521029552 (ea)
- Lot Numbers: 2222832064
- 2301031864
- 2317001864
- 2209526164
- 2215827064
- 2317731864
- 2305204964
- 2305205064
- 2210226764
- 2208817764
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.
See all 10 products in this recall →Related recalls
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