Z-2746-2024 Class II Ongoing
FDA device recall Z-2746-2024 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 4, 2024
- Initiation Date
- Apr 8, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
Medline procedural kits labeled as: 1) BIOPSY PACK, Pack Number DYNJ63370A; 2) CIRCUMCISION TRAY, Pack Number CIT7210; 3) CIRCUMCISION TRAY, Pack Number DYNDA2271; 4) MERCY MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 5) UCLA - BREAST BIOPSY KITDYNDH1512A
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
Code Information
1) DYNJ63370A , Lot Number 23IMB164 ; 2) CIT7210, Lot Number 2022101890; 3) DYNDA2271, Lot Number 2023090790; 4) CIT6780, Lot Number 2022101890; 5) DYNDH1512A, Lot Number 2023090790
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2746-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026