Z-2755-2024 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) CIRCUMCISION TRAY, Pack Number CIT6715; 2) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 3) PORT DRESSING CHANGE TRAY, Pack Number DT18415; 4) UCLA - BREAST BIOPSY KIT, Pack Number DYNDH1512
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
CIT6715, Lot Number 2023011090; CIT6920, Lot Number 2021081890; DT18415 , Lot Number 22OBA722 ; DT18415 , Lot Number 22JBQ737 ; DT18415 , Lot Number 23BBE570 ; DT18415 , Lot Number 23DBS680 ; DT18415 , Lot Number 23EBS516 ; DT18415 , Lot Number 23HBN856 ; DT18415 , Lot Number 23JBV086 ; DT18415 , Lot Number 21BBF570 ; DT18415 , Lot Number 21CBO659 ; DT18415 , Lot Number 24CBM583 ; DYNDH1512, Lot Number 2021120690