Z-0529-2024 Class II Ongoing
FDA device recall Z-0529-2024 was initiated by MEDLINE INDUSTRIES, LP - Northfield on November 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: 1950 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 20, 2023
- Initiation Date
- November 3, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1950 units
Product Description
PVP SOLUTION SING STRL, REF DYNDA1858
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 40889942539858 (case), 10889942539857 (each), Lot numbers: 2023032090, 2023020990, 2022103190, 2022091690, 2022070190, 2022052090, 2022042290, 2022033190, 2021102290, 2021092190