Z-3003-2024 Class II Ongoing
FDA device recall Z-3003-2024 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) NHP BREAST BIOPSY PACK, Pack Number DYNJ17400B; 2) BREAST BIOPSY TRAY, Pack Number DYNJ32049A ; 3) BREAST BIOPSY PACK, Pack Number DYNJ44987G ; 4) BREAST BIOPSY PACK, Pack Number DYNJ66288
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
DYNJ17400B, Lot Number 23ABV075; DYNJ17400B, Lot Number 23ABV141; DYNJ17400B, Lot Number 22KBA557; DYNJ17400B, Lot Number 22GBJ307; DYNJ17400B, Lot Number 22DBU457; DYNJ32049A , Lot Number 19AKB211 ; DYNJ32049A , Lot Number 19CKA247 ; DYNJ44987G , Lot Number 21FBJ607 ; DYNJ44987G , Lot Number 21IBE237 ; DYNJ44987G , Lot Number 21KBA883 ; DYNJ44987G , Lot Number 21LBO984 ; DYNJ44987G , Lot Number 22CBN087 ; DYNJ44987G , Lot Number 20BBQ959 ; DYNJ44987G , Lot Number 20FBI170 ; DYNJ44987G , Lot Number 20JBL731 ; DYNJ44987G , Lot Number 21ABF141 ; DYNJ44987G , Lot Number 21CBF976 ; DYNJ44987G , Lot Number 21DBW445 ; DYNJ66288, Lot Number 20DBE878
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3003-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026