Z-2043-2020 Class II Terminated
FDA device recall Z-2043-2020 was initiated by Medline Industries Inc on May 28, 2019 and is designated Class II. Reason for recall: Loose silicone particulate was found to be present on the shaft of the silicone catheters. The recall status is terminated (terminated January 30, 2023). Affected quantity: 0.
Recall Details
- Product Type
- Devices
- Report Date
- May 27, 2020
- Initiation Date
- May 28, 2019
- Termination Date
- January 30, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 0
Product Description
SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 8 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.
Reason for Recall
Loose silicone particulate was found to be present on the shaft of the silicone catheters.
Distribution Pattern
US Nationwide distribution including in the states of CO, IL, KY, MO, NJ, OR, TN, TX, VA, WA.
Code Information
GTIN 40080196848837 Model DYND11553 lot 287181201.