Medline Recalls Silicone Foley Catheters Due to Loose Particulate
Medline Industries is recalling specific lots of silicone Foley catheters because loose silicone particulate was found on the device shaft.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves loose particulate on a medical device, which presents a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Medline Industries Inc is recalling specific units of the SELECTSILICONE 100% Silicone Foley Catheter, 2-Way, 10 Fr, 3 ml. The recall involves product with GTIN 40884389034423, Model DYND11554, and Lot 287181201.
The recall was initiated because loose silicone particulate was found to be present on the shaft of the silicone catheters. The affected products were distributed nationwide in the United States, including in the states of Colorado, Illinois, Kentucky, Missouri, New Jersey, Oregon, Tennessee, Texas, Virginia, and Washington.
Healthcare facilities and consumers should stop using the affected catheters and contact Medline Industries for further instructions or a replacement.
The recalled product
- 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 inserted through the urethra and used to drain urine into a collection device.
- Manufacturer
- Medline Industries Inc
- Category
- Medical Device — Catheters
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 (1)
- GTIN 40884389034423 Model DYND11554 lot 287181201.
Distribution
Part of a larger recall action
This product is one of 3 recalled by Medline Industries Inc 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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