Dover Irrigation Convenience Kits Recalled for Component Defects
Cardinal Health is recalling Dover Irrigation convenience kits that contained components which were separately recalled. The recall affects over 63,000 units distributed across 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 applies, which mandates a minimum severity score of 4 per the rubric. Although the source does not specify the nature of the component defect or report illnesses or injuries, the Class I designation indicates serious potential for harm.
Plain-English summary
Cardinal Health 200, LLC is recalling Dover Irrigation convenience kits. The kits contain components that were subsequently recalled by Nurse Assist.
The recalled kits include a 1200 CC irrigation tray, 60 CC piston syringe, sterile saline, tip protector, alcohol, and lid. Approximately 63,360 units have been distributed in the United States and internationally, including EMEA, Japan, and Latin America.
Specific lot numbers affected include: 2217401764, 2305706564, 2200426764, 2201121964, 2212328164, 2213015364, 2213709164, 2215108864, 2232203764, 2312920864, and 2313507064.
Consumers and healthcare facilities should immediately cease use of affected kits. For more information, contact Cardinal Health 200, LLC or consult the FDA recall notice.
The recalled product
- Product
- Dover" IRRIGATION 1200 CC TRAY, 60 CC PISTON SYRINGE, STERILE SALINE, TIP PROTECTOR, ALCOHOL, LIDDED
- Manufacturer
- Cardinal Health 200, LLC
- Hazard
- Affected units
- 63,360
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 (12)
- 66820
- Lot Numbers: 2217401764
- 2305706564
- 2200426764
- 2201121964
- 2212328164
- 2213015364
- 2213709164
- 2215108864
- 2232203764
- 2312920864
- 2313507064
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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