FDA Device recall Z-1098-2024
MEDLINE Kits, trays, and packs labeled as follows: a) Description, REF DYNDH1679
- 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) Description, REF DYNDH1679 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-1098-2024 |
| 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) Description, REF DYNDH1679; b) BREAST BIOPSY TRAY, REF DYNDH1664; c) BREAST BIOPSY TRAY, REF DYNDH1431A; d) BREAST BIOPSY TRAY, REF DYNJ46448; e) BREAST BIOPSY TRAY, REF DYKE1520B; f) COLON KIT- BERLIN, REF DYNDH1808;
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 DYNDH1679, UDI/DI 40653160991534 (case), 10195327007041 (unit), Lot Numbers: DYNDH1431A; b) REF DYNDH1664, UD…a) REF DYNDH1679, UDI/DI 40653160991534 (case), 10195327007041 (unit), Lot Numbers: DYNDH1431A; b) REF DYNDH1664, UDI/DI 40193489993930 (case), 10193489993929 (unit), Lot Numbers: DYNDH1664; c) REF DYNDH1431A, UDI/DI 40889942880486 (case), 10889942880485 (unit), Lot Numbers: DYNDH1679; d) REF DYNJ46448, UDI/DI 40888277261465 (case), 10888277261464 (unit), Lot Numbers: 23ADA841; e) REF DYKE1520B, UDI/DI 40193489374958 (case), 10193489374957 (unit), Lot Numbers: 22ABB336, 22EBF090, 22FBF262, 22GBI072, 22HBE089, 22JBW122, 22OBH222, 23ABI623, 23BBL273, 23DBF391, 23FBJ442; f) REF DYNDH1808, UDI/DI 40195327264308 (case), 10195327264307 (unit), Lot Numbers: DYNDH1808, DYNDH1808, DYNDH1808 |
|---|
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-1098-2024%22
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