Z-0162-2025 Class II Ongoing
FDA device recall Z-0162-2025 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Sep 4, 2024 and is designated Class II. Reason for recall: It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is… The recall status is ongoing. Affected quantity: 1180 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 30, 2024
- Initiation Date
- Sep 4, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1180 units
Product Description
Medline CENTRAL CATHETER INSERTION TRA, REF CVI680C; medical procedure convenience kit
Reason for Recall
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Panama.
Code Information
UDI/DI 40653160992944 (each), 10653160992943 (case) , Lot Numbers: 23LBO846
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0162-2025
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026