Z-2775-2024 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
Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAPH TRAY, Pack Name MNS12670A; 2) BREAST BIOPSY KIT, Pack Name DYNDH1512A; 3) CIRCUMCISION TRAY, Pack Name CIT6720; 4) CIRCUMCISION TRAY, Pack Name CIT6715; 5) CIRCUMCISION TRAY, Pack Name CIT7020; 6) CIRCUMCISION TRAY, Pack Name DYNDA2271; 7) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Name CIT6920; 8) NURSERY CIRCUMCISION TRAY, Pack Name CIT4845; 9) PUNCH BIOPSY KIT, Pack Name MNS8245; 10) STERILE 1CC SYR W/ 27GX1/2 NDL, Pack Name DYNDA2496
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 distribution.
Code Information
MNS12670A, Lot Number 2022011090; MNS12670A, Lot Number 2022070690; MNS12670A, Lot Number 2023022190; MNS12670A, Lot Number 2023101890; MNS12670A, Lot Number 2024021590; DYNDH1512A, Lot Number 2022121990; DYNDH1512A, Lot Number 2023101890; CIT6720, Lot Number 2021061490; CIT6715, Lot Number 2022100490; CIT7020, Lot Number 2023010690; DYNDA2271, Lot Number 2023022190; CIT6715, Lot Number 2023082290; CIT7020, Lot Number 2023101890; CIT6715, Lot Number 2023102090; CIT6715, Lot Number 2023120590; CIT6920, Lot Number 2021082390; CIT4845, Lot Number 2021122150; CIT4845, Lot Number 2022052450; MNS8245, Lot Number 2023082490; DYNDA2496, Lot Number 2023012790