MEDLINE INDUSTRIES, LP – Northfield Recall 94586
Description: Centurion procedure packs, containing Caina syringes, labeled as: 1) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 2) RETINAL INJECTION KIT, Pack Number MNS12465
MEDLINE INDUSTRIES, LP – Northfield Recall 94586 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2774-2024 |
| Event ID | 94586 |
| Event Description | Centurion procedure packs, containing Caina syringes, labeled as: 1) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 2) RETINAL INJECTION KIT, Pack Number MNS12465 |
| 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 | CIT6920, Lot Number 2021092290; MNS12465, Lot Number 2022040190 |
| 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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