Z-0349-2025 Class II Ongoing
FDA device recall Z-0349-2025 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Oct 4, 2024 and is designated Class II. Reason for recall: Products within a Medline pack may be impacted by a packaging error in which an incomplete seal has formed on the packaging thereby creating a packaging seal gap. The recall status is ongoing. Affected quantity: 36 units.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 20, 2024
- Initiation Date
- Oct 4, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 36 units
Product Description
CARROLLTON HIP FX Convenience kit used for surgical procedures, SKU SYNJ910003A
Reason for Recall
Products within a Medline pack may be impacted by a packaging error in which an incomplete seal has formed on the packaging thereby creating a packaging seal gap.
Distribution Pattern
US Nationwide distribution in the state of TN.
Code Information
UDI-DI:10889942848447; Lot Number: 24EBP466
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0349-2025
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026