Z-3000-2024 Class II Ongoing
FDA device recall Z-3000-2024 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: TONSIL & ADENOID PACK, Pack Number DYNJ43427C
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
DYNJ43427C , Lot Number 21HBA933 ; DYNJ43427C , Lot Number 22ABL557 ; DYNJ43427C , Lot Number 22BBL591 ; DYNJ43427C , Lot Number 19ABE939 ; DYNJ43427C , Lot Number 19ABM274 ; DYNJ43427C , Lot Number 19ABT846 ; DYNJ43427C , Lot Number 22DBL373 ; DYNJ43427C , Lot Number 22FBV273 ; DYNJ43427C , Lot Number 22GBE783 ; DYNJ43427C , Lot Number 22HBY245 ; DYNJ43427C , Lot Number 22IBS212 ; DYNJ43427C , Lot Number 19IBD112 ; DYNJ43427C , Lot Number 22KBT930 ; DYNJ43427C , Lot Number 22KBV623 ; DYNJ43427C , Lot Number 19JBZ344 ; DYNJ43427C , Lot Number 23ABM258 ; DYNJ43427C , Lot Number 23CBQ295 ; DYNJ43427C , Lot Number 23DBQ887 ; DYNJ43427C , Lot Number 23EBQ116 ; DYNJ43427C , Lot Number 20BBH601 ; DYNJ43427C , Lot Number 23GBI661 ; DYNJ43427C , Lot Number 20DBE542 ; DYNJ43427C , Lot Number 23HBQ003 ; DYNJ43427C , Lot Number 20EBM157 ; DYNJ43427C , Lot Number 23JBX153 ; DYNJ43427C , Lot Number 20GBU737 ; DYNJ43427C , Lot Number 20HBR283 ; DYNJ43427C , Lot Number 23LBR867 ; DYNJ43427C , Lot Number 20IBB669 ; DYNJ43427C , Lot Number 20IBK144
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3000-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026