Z-3013-2024 Class II Ongoing
FDA device recall Z-3013-2024 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: 1) CYSTO PACK, Pack Number DYNJ42742D; 2) CYSTO PACK, Pack Number DYNJ42799
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
DYNJ42742D , Lot Number 19ABF928 ; DYNJ42742D , Lot Number 19BBC938 ; DYNJ42742D , Lot Number 19PBB060 ; DYNJ42742D , Lot Number 19GBO530 ; DYNJ42742D , Lot Number 19HBH965 ; DYNJ42742D , Lot Number 19HBJ692 ; DYNJ42799, Lot Number 21GBH529 ; DYNJ42799, Lot Number 19CBO493 ; DYNJ42799, Lot Number 19EBF614 ; DYNJ42799, Lot Number 19FBD772 ; DYNJ42799, Lot Number 19GBE887 ; DYNJ42799, Lot Number 19HBI404 ; DYNJ42799, Lot Number 19IBT472 ; DYNJ42799, Lot Number 20ABD578 ; DYNJ42799, Lot Number 20CBF124 ; DYNJ42799, Lot Number 20DBC424 ; DYNJ42799, Lot Number 20EBT962 ; DYNJ42799, Lot Number 20JBF487 ; DYNJ42799, Lot Number 20JBZ120 ; DYNJ42799, Lot Number 21ABV059 ; DYNJ42799, Lot Number 21BBM615 ; DYNJ42799, Lot Number 21EBP168 ; DYNJ42799, Lot Number 21EBP171
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3013-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026