Z-3043-2024 Class II Ongoing
FDA device recall Z-3043-2024 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Apr 8, 2024 and is designated Class II. Reason for recall: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to… The recall status is ongoing.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 18, 2024
- Initiation Date
- Apr 8, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
Medline Convenience kits labeled as: HSG TRAY, Pack Number DYNDH1453
Reason for Recall
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Distribution Pattern
Worldwide distribution.
Code Information
DYNDH1453, Lot Number 20EBA949 ; DYNDH1453, Lot Number 21ABR125 ; DYNDH1453, Lot Number 22FMA793 ; DYNDH1453, Lot Number 22HMD391 ; DYNDH1453, Lot Number 22HMD549
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3043-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026