FDA Device recall Z-1103-2024
MEDLINE Kits, trays, and packs labeled as follows: a) C-SECTION, REF DYNJ904653G
- FDA Device
- Class I
- ongoing
- Published 2024-03-06
On 2024-03-06 the FDA classified a Class I recall of MEDLINE Kits, trays, and packs labeled as follows: a) C-SECTION, REF DYNJ904653G by Medline Industries Northfield, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1103-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-11-15 |
| Published | 2024-03-06 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
MEDLINE Kits, trays, and packs labeled as follows: a) C-SECTION, REF DYNJ904653G; b) DRESSING TRAY, REF M101426; c) ENDO KIT, REF DYKE1387; d) ENDO KIT, REF DYKE1364B; e) ENDO KIT, REF DYKE1892; f) ENDO KIT W/ BLUE TOTE BAG, REF DYKE1648I; g) EYE KIT, REF DYKM2222; h) LAP CHOLE CDS, REF CDS983912Y; i) PLASTICS SUTURE TRAY, REF SUT13535; j) SNES ENDO KIT, REF DYKE1930A
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.
Identifiers
| code_info | a) REF DYNJ904653G, UDI/DI 40195327279951 (case), 10195327279950 (unit), Lot Numbers: 23ABE326; b) REF M101426, UDI…a) REF DYNJ904653G, UDI/DI 40195327279951 (case), 10195327279950 (unit), Lot Numbers: 23ABE326; b) REF M101426, UDI/DI 40195327279951 (case), 10195327279950 (unit), Lot Numbers: 23ABD269; c) REF DYKE1387, UDI/DI 40889942384007 (case), 10889942384006 (unit), Lot Numbers: 22FBC677, 22FBU123, 22HBA432, 22JBG195, 23ABF156, 23BBE110, 23CBG139, 23CBU443; d) REF DYKE1364B, UDI/DI 40195327162734 (case), 10195327162733 (unit), Lot Numbers: 22FBV837, 22HBL534, 22IMH103, 22KMA408, 22LMG525; e) REF DYKE1892, UDI/DI 40195327279951 (case), 10195327279950 (unit), Lot Numbers: 23ABD211, 23CBX144, 23FBN050; f) REF DYKE1648I, UDI/DI 40195327279951 (case), 10195327279950 (unit), Lot Numbers: 23CBX187; g) REF DYKM2222, UDI/DI 40195327279951 (case), 10195327279950 (unit), Lot Numbers: 23FBO502; h) REF CDS983912Y, UDI/DI 40195327279951 (case), 10195327279950 (unit), Lot Numbers: 23FBO144 i) REF SUT13535, UDI/DI 40195327279951 (case), 10195327279950 (unit), Lot Numbers: 23CBX181; j |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1103-2024%22
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