Z-2770-2024 Class II Ongoing
FDA device recall Z-2770-2024 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
Centurion procedure kits labeled as: 1) BONE MARROW TRAY, Pack Number SPEC0255; 2) CT/ULTRASOUND BIOPSY, Pack Number SPEC0262; 3) FINE LACERATION KIT, Pack Number SUT17215; 4) INFECTION DRIVELINE MANAGEMENT KIT, Pack Number DM645; 5) LACERATION TRAY, Pack Number DYNDL1159B; 6) SUTURE TRAY, Pack Number DYNDS1064B
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
SPEC0255, Lot Number 2020042080: SPEC0262, Lot Number 2018111280: SUT17215, Lot Number 2020042080: DM645, Lot Number 2018111280: DM645, Lot Number 2020042080: DM645, Lot Number 2022020780: DYNDL1159B, Lot Number 2018111280: DYNDS1064B, Lot Number 2020042080
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2770-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026