Z-2593-2025 Class I Ongoing
FDA device recall Z-2593-2025 was initiated by Medline Industries, LP on August 8, 2025 and is designated Class I. Reason for recall: Convenience kits labeled as sterile have not gone through the sterilization process. The recall status is ongoing. Affected quantity: 88 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 8, 2025
- Initiation Date
- August 8, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 88 units
Product Description
Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B
Reason for Recall
Convenience kits labeled as sterile have not gone through the sterilization process.
Distribution Pattern
US Distribution to States of: FL, MD, NJ, TN
Code Information
1) DYNJ45701B, UDI-DI: 10193489856279(each), 40193489856270(case), Lot Number: 25GBF686