MEDLINE INDUSTRIES, LP – Northfield Recall 93800
Description: Medline Kits, trays, and packs labeled as follows: a) ER LACERATION TRAY - SNAG FREE, REF SUT12825; b) LACERATION TRAY, REF SUT21580; c) LACERATION TRAY, REF DYNDL1484B;
MEDLINE INDUSTRIES, LP – Northfield Recall 93800 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1118-2024 |
| Event ID | 93800 |
| Event Description | Medline Kits, trays, and packs labeled as follows: a) ER LACERATION TRAY - SNAG FREE, REF SUT12825; b) LACERATION TRAY, REF SUT21580; c) LACERATION TRAY, REF DYNDL1484B; |
| Product Type | Devices |
| Distribution | Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama |
| Quantity | 12000 units |
| Recall Reason | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile. |
| Device Classification | 20240306 |
| Device Code Info | a) REF SUT12825, UDI/DI 00653160356199 (case), 10653160356196 (unit), Lot Numbers: 23CBX773, 23EBB756, 23HBC776; b) REF SUT21580, UDI/DI 40653160991077 (case), 10653160991076 (unit), Lot Numbers: 22EBC554, 22EBK107, 22EBR701, 22GBW369, 22JBI962, 22KBA966, 23DBD424, 23FBK832, 23GBR277, 23HBX352,; c) REF DYNDL1484B, UDI/DI 20193489198741 (case), 10193489198744 (unit), Lot Numbers: 22HLB333, 22ILA328, 22KLA754, 22LLA450, 23ALA763, 23BLA321, 23BLA885, 23CLA874, 23FLA147, 23FLB061, 23HLA382 |
| Center Classification Date | 20240224 |
| Recall Initiation Date | 20231115 |
| Recalling Firm | MEDLINE INDUSTRIES, LP - Northfield |
| Initial Notification | Letter |
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