Z-3053-2024 Class II Ongoing
FDA device recall Z-3053-2024 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) C SCOPE DISPOSABLE KIT, Pack Code 613034700; 2) C SCOPE DISPOSABLE KIT, Pack Code 613034701; 3) C SCOPE DISPOSABLE KIT, Pack Code 613034702
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
613034700, Lot Number 20ADD340 ; 613034700, Lot Number 20BDC393 ; 613034700, Lot Number 20BDC472 ; 613034700, Lot Number 20BDC473 ; 613034700, Lot Number 20FDA390 ; 613034700, Lot Number 20FDA896 ; 613034700, Lot Number 20FDA897 ; 613034700, Lot Number 20FDA898 ; 613034700, Lot Number 20FDA896A; 613034700, Lot Number 20JDB120 ; 613034700, Lot Number 21CDA660 ; 613034700, Lot Number 21DDB193 ; 613034700, Lot Number 21IDA396 ; 613034700, Lot Number 21LDB900 ; 613034700, Lot Number 22ADB549 ; 613034701, Lot Number 21CDA617 ; 613034701, Lot Number 21DDB192 ; 613034701, Lot Number 21IDB791 ; 613034701, Lot Number 21JDB094 ; 613034701, Lot Number 22BDB700 ; 613034702, Lot Number 21CDA618 ; 613034702, Lot Number 21DDB222 ; 613034702, Lot Number 21IDB804 ; 613034702, Lot Number 21LDB713
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3053-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026