Z-0534-2025 Class II Ongoing
FDA device recall Z-0534-2025 was initiated by MEDLINE INDUSTRIES, LP - Northfield on October 15, 2024 and is designated Class II. Reason for recall: Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length. The recall status is ongoing. Affected quantity: 48 kits.
Recall Details
- Product Type
- Devices
- Report Date
- December 4, 2024
- Initiation Date
- October 15, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 48 kits
Product Description
Medline Shoulder Repair Pack-LF, REF DYNJ82607, 2 kits/case, sterile.
Reason for Recall
Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
Distribution Pattern
US Nationwide distribution in the states of AL, GA, MA, NJ, and PA.
Code Information
Lot number 24ABO552, exp. 9/30/2025, UDI-DI each 10195327198930, UDI-DI case 40195327198931.