Z-0528-2024 Class II Ongoing
FDA device recall Z-0528-2024 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Nov 3, 2023 and is designated Class II. Reason for recall: The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile. The recall status is ongoing. Affected quantity: 700 units.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 20, 2023
- Initiation Date
- Nov 3, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 700 units
Product Description
STERILE PVP, REF DYNDA1649
Reason for Recall
The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.
Distribution Pattern
US Nationwide distribution in the states of CT, IA, LA, MA, PA, CA, NY, FL.
Code Information
UDI/DI 40889942326519 (case), 10889942326518 (each), Lot numbers: 2022060190, 2022021590
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0528-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026