Device product
Medline Convenience kits labeled as: HSG TRAY, Pack Number DYNDH1453
Z-3043-2024
Product summary
- Event
- Event 94583
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-3043-2024
Official wording
Reason: 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.
Code information: DYNDH1453, Lot Number 20EBA949 ; DYNDH1453, Lot Number 21ABR125 ; DYNDH1453, Lot Number 22FMA793 ; DYNDH1453, Lot Number 22HMD391 ; DYNDH1453, Lot Number 22HMD549
Distribution pattern: Worldwide distribution.
Derived failure modes
-
Unknown
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.