Z-2740-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 4, 2024
- Initiation Date
- April 8, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
Medline procedural kits labeled as: 1) BABY CARE KIT UNIV, Pack Number DYKL1025; 2) BABY CARE KIT UNIV, Pack Number DYKL1025H
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
Code Information
DYKL1025 , Lot Number 21JBA955 ; DYKL1025 , Lot Number 21LBX335 ; DYKL1025 , Lot Number 22BBW368 ; DYKL1025 , Lot Number 22FBT155 ; DYKL1025 , Lot Number 22IBA604 ; DYKL1025 , Lot Number 22JBJ323 ; DYKL1025 , Lot Number 23ABH574 ; DYKL1025 , Lot Number 23ABS213 ; DYKL1025 , Lot Number 23CBT397 ; DYKL1025 , Lot Number 23FBI255 ; DYKL1025 , Lot Number 23GBF800 ; DYKL1025 , Lot Number 23IBN598 ; DYKL1025H, Lot Number 21JBA955 ; DYKL1025H, Lot Number 21LBX335 ; DYKL1025H, Lot Number 22BBW368 ; DYKL1025H, Lot Number 22FBT155 ; DYKL1025H, Lot Number 22IBA604 ; DYKL1025H, Lot Number 22JBJ323 ; DYKL1025H, Lot Number 23ABH574 ; DYKL1025H, Lot Number 23ABS213 ; DYKL1025H, Lot Number 23CBT397 ; DYKL1025H, Lot Number 23FBI255 ; DYKL1025H, Lot Number 23GBF800 ; DYKL1025H, Lot Number 23IBN598