Z-1807-2024 Class II Ongoing
FDA device recall Z-1807-2024 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Mar 12, 2024 and is designated Class II. Reason for recall: Products have a lack of sterility assurance. The recall status is ongoing. Affected quantity: 50 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 22, 2024
- Initiation Date
- Mar 12, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50 units
Product Description
Namic FLUID DELIVERY SET, REF 91300040
Reason for Recall
Products have a lack of sterility assurance.
Distribution Pattern
US Nationwide distribution in the states of AL, FL, KY, MS, TX, WA, WI, NC, VA, CA, SD, TN, GA, PA, TX.
Code Information
UDI/DI 20193489069096 (box), 10193489069099 (unit), Lot Numbers: 0000113381
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1807-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026