Z-0154-2025 Class II Ongoing
FDA device recall Z-0154-2025 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: 312 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 30, 2024
- Initiation Date
- Sep 4, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 312 units
Product Description
Medline brand, medical procedure convenience kits, labeled as: a) SET UP PACK, REF DYNJ36320A; b) ANGIOGRAM WRO-LF, REF DYNJ41876B
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
a) DYNJ36320A, UDI/DI 40889942245230 (each), 10889942245239 (case), Lot Numbers: 24ABC836; b) DYNJ41876B, UDI/DI 40193489563086 (each), 10193489563085 (case), Lot Numbers: 23LBM850
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0154-2025
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026