Device product
Medline procedural kits labeled as: UMBILICAL LINE KIT W/FOAM, Pack Number DYNDL1588A
Z-2753-2024
Product summary
- Event
- Event 94581
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-2753-2024
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: DYNDL1588A , Lot Number 23ELA011 ; DYNDL1588A , Lot Number 23HLA426 ; DYNDL1588A , Lot Number 23JLA181 ; DYNDL1588A , Lot Number 24ALA515
Distribution pattern: Worldwide
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.