Dover Foley Catheter Kits Recalled Due to Defective Components
Cardinal Health is recalling 4,620 Dover Foley catheter convenience kits due to components that were recalled by Nurse Assist. The kits, distributed in the US, EMEA, Japan, and Latin America, contain silicone and latex catheters.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification indicates serious health risk to users of this medical device, meeting the minimum threshold for Severe severity per the rubric. No deaths or reported illnesses are documented in the recall notice.
Plain-English summary
Cardinal Health 200, LLC is recalling 4,620 Dover brand Foley catheter convenience kits. The kits contain components that were subsequently recalled by Nurse Assist, a supplier of components used in these medical devices.
The affected kits are distributed in the United States, EMEA (Europe, Middle East, Africa), Japan, and Latin America. The products include multiple configurations of silicone and latex Foley trays with various sizes and features, such as Luer Lock, Coude Tip, and silver-hydrogel coatings.
The FDA classified this as a Class I recall. Patients or healthcare providers who have these products should contact Cardinal Health 200, LLC for further instructions or product replacement information.
The recalled product
- Product
- Dover" 100% SILICONE FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 16 FR (5.3 MM), 5 CC, 2000 ML D
- Manufacturer
- Cardinal Health 200, LLC
- Hazard
- Affected units
- 4,620
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) 6146LL
- UDI/DI 30884521015504 (cs)
- 10884521015500 (ea)
- Lot Numbers: 2222830564
- 2234606164
- 2300129064
- 2300129264
- 2206723564
- 2206723664
- 2213047764
- 2213741964
- 2214452664
- 2216503164
- 2211628464
- 2225100964
- 2305403264
- 2207404564
- 2203933464
- 2209525664
- 2210210364
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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