Z-0535-2024 Class II Ongoing
FDA device recall Z-0535-2024 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Oct 19, 2023 and is designated Class II. Reason for recall: Undeclared latex The recall status is ongoing. Affected quantity: 144 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 20, 2023
- Initiation Date
- Oct 19, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 144 devices
Product Description
Medline Leg bag, REF URO12573
Reason for Recall
Undeclared latex
Distribution Pattern
US and Panama
Code Information
UDI/DI 20888277719290 (case), 10888277719293 (insert), Lot Numbers: 48623050001, 48623060001
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0535-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026