Agency classClass IOur severity:Severe FDA (Devices)·Z-1052-2024·Announced 2024-02-28

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.

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: 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
Affected units: 924

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.

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 →

Same manufacturer · Cardinal Health 200, LLC

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Same hazard · component defect