FDAClass IFebruary 28, 2024

Dover" 100% Silicone Foley Tray recall

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…

Why was Dover" 100% Silicone Foley Tray recalled?

Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

1814, UDI/DI 20884521003528 (cs), 10884521003521 (ea), Lot Numbers: 22210206164, 2211627364, 2231919964

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…
Recalling firm
Cardinal Health 200, LLC
Quantity
924 units
Distribution
US and EMEA, Japan, Latin America
Recall date
February 28, 2024
Classification
Class I
Status
Ongoing
Agency
FDA (device)
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