FDAClass IIMay 27, 2020

Selectsilicone" 100% Silicone Foley Catheter 2-way 10 recall: Particulate Matter

SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 10 Fr 3 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is…

Why was Selectsilicone" 100% Silicone Foley Catheter 2-way 10 recalled?

Loose silicone particulate was found to be present on the shaft of the silicone catheters.

What should I do if I have this product?

Review the official FDA enforcement record for current 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?

GTIN 40884389034423 Model DYND11554 lot 287181201.

Product
SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 10 Fr 3 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is…
Recalling firm
Medline Industries Inc
Quantity
0
Distribution
US Nationwide distribution including in the states of CO, IL, KY, MO, NJ, OR, TN, TX, VA, WA.
Recall date
May 27, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls