MEDLINE INDUSTRIES, LP – Northfield Recall 94586
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
MEDLINE INDUSTRIES, LP – Northfield Recall 94586 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2775-2024 |
| Event ID | 94586 |
| Event 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 |
| Product Type | Devices |
| Distribution | Worldwide distribution. |
| Recall Reason | 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. |
| Device Classification | 20240904 |
| Device Code Info | 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 |
| Center Classification Date | 20240828 |
| Recall Initiation Date | 20240408 |
| Recalling Firm | MEDLINE INDUSTRIES, LP - Northfield |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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