Z-3043-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 18, 2024
- Initiation Date
- April 8, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
Medline Convenience kits labeled as: HSG TRAY, Pack Number DYNDH1453
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
DYNDH1453, Lot Number 20EBA949 ; DYNDH1453, Lot Number 21ABR125 ; DYNDH1453, Lot Number 22FMA793 ; DYNDH1453, Lot Number 22HMD391 ; DYNDH1453, Lot Number 22HMD549