Dover Foley Catheter Kits and Drain Trays Recalled
Dover Foley catheter kits and silicone drain trays manufactured with subsequently recalled components were distributed to 924 units across the US, EMEA, Japan, and Latin America.
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: This recall received an FDA Class I classification, the highest severity designation for medical devices, indicating potential for serious adverse health consequences. However, no illnesses, injuries, or deaths are reported in the source material.
Plain-English summary
This recall concerns Dover convenience kits containing 100% silicone Foley trays (needleless, 14 FR, 5 CC, 2000 ML drain bag) and hydrogel-coated latex Foley catheter kits (5 CC, 2-way, 14 FR, with 10 CC water syringe). These kits were manufactured by Cardinal Health 200, LLC, with 924 units affected by this Class I recall.
The kits contained components that were subsequently recalled by Nurse Assist. The FDA designated this as a Class I recall based on the recalled components included in the kits.
The affected products were distributed to the US, EMEA, Japan, and Latin America. Specific lot numbers for the recalled kits are 22210206164, 2211627364, and 2231919964. The UDI/DI codes are 20884521003528 (case) and 10884521003521 (each unit).
The recalled product
- Product
- Dover" 100% SILICONE FOLEY TRAY, NEEDLELESS, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover" HYDROGEL COATED LATEX FOLEY CATHETER KIT, 5 CC, 2-WAY, 14 FR (4.7 MM), 10 CC WATER SYRINGE
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device
- Hazard
- component-defect
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 (6)
- 1814
- UDI/DI 20884521003528 (cs)
- 10884521003521 (ea)
- Lot Numbers: 22210206164
- 2211627364
- 2231919964
Distribution
Distribution scope not specified by the agency.
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