FDA Device recall Z-1095-2024
MEDLINE Kits, trays, and packs labeled as follows: a) CATH LAB CDS, REF CDS840228F
- 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) CATH LAB CDS, REF CDS840228F 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-1095-2024 |
| 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) CATH LAB CDS, REF CDS840228F; b) PEDIATRIC PORT A CATH TRAY, REF DYNDC2128B; c) PK, RADIOLOGY, REF DYNJ44087A; d) PORT ACCESS PACK-LF, REF DYNJ0352159C; DYNJ0352159D
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 CDS840228F, UDI/DI 40889942778547 (case), 10889942778546 (unit), Lot Numbers: 22CLA155, 22FLA788, 22GLA774, 22K…a) REF CDS840228F, UDI/DI 40889942778547 (case), 10889942778546 (unit), Lot Numbers: 22CLA155, 22FLA788, 22GLA774, 22KLB047, 23CLA672, 23CLA832, 23ELA032, 23FLA055, 23FLA663; b) REF DYNDC2128B, UDI/DI 40195327249114 (case), 10195327249113 (unit), Lot Numbers: 22IBG388; c) REF DYNJ44087A, UDI/DI 40889942561804 (case), 10889942561803 (unit), Lot Numbers: 21112457, 22022812, 22022812, 22022812, 22094063, 22104208, 22032993, 21112457, 22104208; d) REF DYNJ0352159C, UDI/DI 40889942622581 (case), 10889942622580 (unit), Lot Numbers: 22FBH338, 22OBE815; REF DYNJ0352159D, UDI/DI 40195327196616 (case), 10195327196615 (unit), Lot Numbers: 23AME808, 23EMI159, 23FME004, 23JMJ796 |
|---|
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-1095-2024%22
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