MEDLINE INDUSTRIES, LP - Northfield: Medical Device Recall in 2024 - (Recall #: Z-2776-2024)
See the recall detail below. You can also see other recalls from the same firm in 2024.
Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAM, Pack Number DYNDH1446A; 2) ARTHROGRAM TRAY, Pack Number MNS11965A; 3) ARTHROGRAPH TRAY, Pack Number MNS12670A; 4) BREAST BIOPSY KIT, Pack Number DYNDH1512; 5) CIRCUMCISION KIT, Pack Number CIT6535; 6) CIRCUMCISION KIT, Pack Number CIT7095; 7) CIRCUMCISION TRAY, Pack Number CIT7020; 8) CIRCUMCISION TRAY, Pack Number CIT6720; 9) CIRCUMCISION TRAY, Pack Number CIT6715; 10) CIRCUMCISION TRAY, Pack Number CIT7210; 11) CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6925; 12) DISPOSABLE NICU UMBILICAL INSERTION TRAY, Pack Number UVT1030; 13) MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 14) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 15) NURSERY CIRCUMCISION TRAY, Pack Number CIT4845; 16) PUNCH BIOPSY KIT, Pack Number MNS8245; 17) RETINAL INJECTION KIT, Pack Number MNS12465; 18) STERILE 1CC SYR W/ 27GX1/2 NDL, Pack Number DYNDA2496
Class II
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.
DYNDH1446A, Lot Number 2020102990; MNS11965A, Lot Number 2021061190; MNS11965A, Lot Number 2021072690; MNS11965A, Lot Number 2021083090; MNS11965A, Lot Number 2022041390; MNS11965A, Lot Number 2022091490; MNS11965A, Lot Number 2023041090; MNS12670A, Lot Number 2023060290; DYNDH1512, Lot Number 2021100490; CIT7095, Lot Number 2021061190; CIT6535, Lot Number 2024031880; CIT7020, Lot Number 2021120990; CIT6720, Lot Number 2022032290; CIT6715, Lot Number 2022062290; CIT7210, Lot Number 2022071990; CIT7020, Lot Number 2022091490; CIT7210, Lot Number 2022120590; CIT6715, Lot Number 2023012490; CIT7020, Lot Number 2023030290; CIT7210, Lot Number 2023030990; CIT7210, Lot Number 2023060290; CIT6925, Lot Number 2021081190; CIT6925, Lot Number 2021090290; CIT6925, Lot Number 2022070590; UVT1030, Lot Number 2021072190; UVT1030, Lot Number 2022032290; CIT6780, Lot Number 2021081650; CIT6780, Lot Number 2023092290; CIT6920, Lot Number 2024020290; CIT4845, Lot Number 2023042090; CIT4845, Lot Number 2023070390; CIT4845, Lot Number 2023081090; MNS8245, Lot Number 2022111890; MNS12465, Lot Number 2022072290; MNS12465, Lot Number 2022111890; MNS12465, Lot Number 2023042890; MNS12465, Lot Number 2023102390; MNS12465, Lot Number 2024022190; MNS12465, Lot Number 2024030790; MNS12465, Lot Number 2022022880; DYNDA2496, Lot Number 2023102590
Worldwide distribution.
Voluntary: Firm initiated