FDA Device recall Z-1125-2024
Medline Kits, trays, and packs labeled as follows: a) D&C CDS, REF CDS983911J
- 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) D&C CDS, REF CDS983911J 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-1125-2024 |
| 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) D&C CDS, REF CDS983911J; b) D&C PACK, REF DYNJ67214F; c) D&C PACK, REF DYNJ67214G
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 CDS983911J, UDI/DI 40193489402668 (case), 10193489402667 (unit), Lot Numbers: 22EBU168, 22KBI115, 22LBL299, 22N…a) REF CDS983911J, UDI/DI 40193489402668 (case), 10193489402667 (unit), Lot Numbers: 22EBU168, 22KBI115, 22LBL299, 22NBD200, 22NBF154, 23ABE617, 23ABU424, 23CBT642, 23IBM022, 23JBC180; b) REF DYNJ67214F, UDI/DI 40195327277803 (case), 10195327277802 (unit), Lot Numbers: 22LBT250, 23BBM551, 23CBS078; c) REF DYNJ67214G, UDI/DI 40195327411306 (case), 10195327411305 (unit), Lot Numbers: 23GBI555 |
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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-1125-2024%22
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