Z-2755-2024 Class II Ongoing
FDA device recall Z-2755-2024 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) CIRCUMCISION TRAY, Pack Number CIT6715; 2) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 3) PORT DRESSING CHANGE TRAY, Pack Number DT18415; 4) UCLA - BREAST BIOPSY KIT, Pack Number DYNDH1512
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
CIT6715, Lot Number 2023011090; CIT6920, Lot Number 2021081890; DT18415 , Lot Number 22OBA722 ; DT18415 , Lot Number 22JBQ737 ; DT18415 , Lot Number 23BBE570 ; DT18415 , Lot Number 23DBS680 ; DT18415 , Lot Number 23EBS516 ; DT18415 , Lot Number 23HBN856 ; DT18415 , Lot Number 23JBV086 ; DT18415 , Lot Number 21BBF570 ; DT18415 , Lot Number 21CBO659 ; DT18415 , Lot Number 24CBM583 ; DYNDH1512, Lot Number 2021120690
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2755-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026