MEDLINE INDUSTRIES, LP – Northfield Recall 94580
Description: Medline procedure kits labeled as: 1) NEPHROLOGY PACK, Pack Number DYNJ59089; 2) NERVE BLOCK TRAY, Pack Number DYNJRA1221A
MEDLINE INDUSTRIES, LP – Northfield Recall 94580 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2443-2024 |
| Event ID | 94580 |
| Event Description | Medline procedure kits labeled as: 1) NEPHROLOGY PACK, Pack Number DYNJ59089; 2) NERVE BLOCK TRAY, Pack Number DYNJRA1221A |
| Product Type | Devices |
| Distribution | Worldwide Distribution: US (nationwide) and OUS countries of: AE, AI, BB, CA, CL, CY, DE, GT, HN, JP, MX, MY, PA, PE, PR, SA, SG, TC, TT, VI, PR, TT, MX, BM, ES, NI, DO, GU, CR, AT, CD, DE, DF, W, and ON. |
| Quantity | 1,679,067 units in total |
| 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 | 20240814 |
| Device Code Info | DYNJ59089 , Lot Number 23IBF074 ; DYNJRA1221A , Lot Number 20IDB255 ; DYNJRA1221A , Lot Number 22BDA978 ; DYNJRA1221A , Lot Number 22KDA950 ; DYNJRA1221A , Lot Number 22LDA146 ; DYNJRA1221A , Lot Number 23ADB422 ; DYNJRA1221A , Lot Number 23BDB453 ; DYNJRA1221A , Lot Number 23IDA424 ; DYNJRA1221A , Lot Number 23JDB010 |
| Center Classification Date | 20240808 |
| 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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