Z-2131-2023 Class II Ongoing
FDA device recall Z-2131-2023 was initiated by MEDLINE INDUSTRIES, LP - Northfield on May 18, 2023 and is designated Class II. Reason for recall: Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING". The recall status is ongoing. Affected quantity: 183240 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 19, 2023
- Initiation Date
- May 18, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 183240 units
Product Description
MEDLINE NON-STERILE PVP SOLUTION, STERILE PACKAGING REF DYNDA2232A
Reason for Recall
Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".
Distribution Pattern
Worldwide distribution - US Nationwide and the country of Panama.
Code Information
GTIN 10889942851850, Batch Numbers: 2023011090, 2023011190, 2023011790, 2023012090, 2023012590, 2023020790, 2023022390, 2023022490