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Recall Observatory FDA recall evidence

Device 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.

Z-2044-2020

May 28, 2019

Class II

Product summary

Firm
Medline Industries Inc
Event
Event 84791
Status
Terminated
Classification
Class II
Quantity
0
Official record key
device-enforcement:Z-2044-2020

Official wording

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

Code information: GTIN 40884389034423 Model DYND11554 lot 287181201.

Distribution pattern: US Nationwide distribution including in the states of CO, IL, KY, MO, NJ, OR, TN, TX, VA, WA.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    particulate