Z-2756-2024 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) OSF SMMC CIRCUMCISION KIT, Pack Number CIT7095; 4) RETINAL INJECTION KIT, Pack Number MNS12465; 5) 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 2023071390; CIT6920, Lot Number 2021071290; CIT7095, Lot Number 2021071290; CIT7095, Lot Number 2022110390; MNS12465, Lot Number 2023081590; DYNDH1512, Lot Number 2021070790; DYNDH1512, Lot Number 2021080290; DYNDH1512, Lot Number 2022011990; DYNDH1512A, Lot Number 2022110390; DYNDH1512A, Lot Number 2023052290; DYNDH1512A, Lot Number 2023071390; DYNDH1512A, Lot Number 2024022690