MEDLINE Kits — Class I medical device recall Z-1096-2024
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2024-03-06, distributed nationwide. Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse
| Recall number | Z-1096-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2023-11-15 |
| Classified | 2024-02-24 |
| Reported by FDA | 2024-03-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CA, PA |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10193489197389, 10193489342567, 10193489913279, 10195327007126, 10195327024635, 10195327034092, 10195327067243, 10195327114084, 10195327151812, 10195327153250, 10195327183837, 10195327346584, 10195327351540, 10195327430962, 10653160994183, 10888277789388, 20193489197386, 40193489342568, 40193489913270, 40195327007127, 40195327024636, 40195327034093, 40195327067244, 40195327114085, 40195327151813 and 7 more |
| Lot numbers | 21LBT706, 22BBY253, 22CBE273, 22CBY383, 22DBG793, 22EBM485, 22FBX071, 22GBO510, 22GBY046, 22HBI240, 22IBF009, 22IBF810, 22ILA769, 22JBQ585, 22JBS870, 22JBT625, 22LBJ398, 22LBQ630, 22LBR066, 22LLA799, 22OBI364, 23ABC131, 23ABP719, 23ABS408, 23BBA069, 23BBG861, 23BBJ268, 23BBK356, 23BBR837, 23BLB093, 23BMF718, 23CBG974, 23CBI370, 23CBM313, 23CBR900, 23CBS913, 23CME669, 23DBE286, 23DBR127, 23EBF536 and 25 more |
| Model numbers | CDS984289K, DM1165, DM1165B, DYKE1346D, DYKE1648G, DYKE1648I, DYKE1892A, DYNDA2212B, DYNDC2842, DYNDC3106, DYNDC3184, DYNDC3192, DYNJ44087B, DYNJ46785C, DYNJ54822D, DYNJ904068D, DYNJ907554A, DYNJ907554C |
Product
MEDLINE Kits, trays, and packs labeled as follows: a) DIALYSIS FISTULA KIT, REF DYNDC3106, b) ENDO KIT, REF DYKE1346D, c) ENDO KIT, REF DYKE1892A, d) ENDO KIT W/ BLUE TOTE BAG, REF DYKE1648G, e) ENDO KIT W/ BLUE TOTE BAG, REF DYKE1648I, f) FREQUENT DAILY VAD, REF DYNDC3184, g) IMPLANTED VASCULAR ACCESS, REF DYNDC2842, h) INFANT COARTATION PACK, REF DYNJ54822D, i) INFANT OPEN HEART PUMP, REF DYNJ904068D, j) INFUSA PORT DRESSING KIT, REF DYNDC3192, k) LVAD DRIVELINE MANAGEMENT KIT, REF DM1165, l) LVAD DRIVELINE MANAGEMENT KIT, REF DM1165B, m) OPEN HEART ACCESSORY CDS, REF CDS984289K, n) PACEMAKER PK SHSC-LF, REF DYNJ46785C, o) PERICARDIAL KIT, REF DYNDA2212B, p) PK, RADIOLOGY-PORTSMOUTH, REF DYNJ44087B, q) PUH PERCUTANEOUS ECMO, REF DYNJ907554A, r) PUH PERCUTANEOUS ECMO, REF DYNJ907554C
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1096-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.