Recall Z-2043-2020
Medline Industries Inc · initiated May 28, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: GTIN 40080196848837 Model DYND11553 lot 287181201.
Reason for recall
Loose silicone particulate was found to be present on the shaft of the silicone catheters.
FDA-determined cause: Manufacturing material removal
Action taken
Medline Industries, Inc. sent formal letters with response forms to each consignee affected via 1st class mail on May 28, 2019. Each consignee was also provided with a response form to return via fax or email. The recalled product that is will be quarantined at the corporate office located at Three Lakes Drive, Northfield, IL 60093-2753 pending destruction.
Details
- Recall number
- Z-2043-2020
- Initiated
- May 28, 2019
- Terminated
- January 30, 2023
- Product code
- EZL – Catheter, Retention Type, Balloon
- Distribution
- US Nationwide distribution including in the states of CO, IL, KY, MO, NJ, OR, TN, TX, VA, WA.
- Recalling firm
- Medline Industries Inc, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2042-2020 Class II | SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 6 Fr 1.5 ml - Product Usage: Medline…Loose silicone particulate was found to be present on the shaft of the silicone catheters. | 05/28/2019Terminated |
| Z-2044-2020 Class II | SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 10 Fr 3 ml - Product Usage: Medline…Loose silicone particulate was found to be present on the shaft of the silicone catheters. | 05/28/2019Terminated |