MEDLINE procedure kits labeled as follows: 1) CONT EPI 20G W/HUSTEAD — Class II medical device recall Z-0513-2025
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2024-12-04, distributed nationwide. The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open po
| Recall number | Z-0513-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2024-10-16 |
| Classified | 2024-11-22 |
| Reported by FDA | 2024-12-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, BM, CA, PA |
| Quantity | 3,744 units |
| UPC / GTIN / UDI-DI | 10195327365417, 10888277748408, 10889942448708, 10889942448715, 10889942757381, 40195327365418, 40888277748409, 40889942448709, 40889942448716, 40889942757382 |
| Lot numbers | 22FLA647, 22FLA675, 22GLA241, 22GLA433, 22GLA470, 22HLB225, 22ILA287, 22ILA288, 23CLA257, 23ELB081 |
| Model numbers | PAIN1069B, PAIN1281, PAIN1941, PAIN9023, PAIN9024 |
Product
MEDLINE procedure kits labeled as follows: 1) CONT EPI 20G W/HUSTEAD, REF PAIN1069B; 2) CSE TRAY, REF PAIN1941; 3) TRAY CON EPID 20G NYL W/TUOHY, REF PAIN9023; 4) TRAY, CONT EPI 20G NYL W/ HUST, REF PAIN1281 5) TRAY, CONT EPI 20G NYL W/ HUST, REF PAIN9024
Reason for recall
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
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-0513-2025. 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.