FDA Device recall Z-0513-2025
MEDLINE procedure kits labeled as follows: 1) CONT EPI 20G W/HUSTEAD, REF PAIN1069B
- FDA Device
- Class II
- ongoing
- Published 2024-12-04
On 2024-12-04 the FDA classified a Class II recall of MEDLINE procedure kits labeled as follows: 1) CONT EPI 20G W/HUSTEAD, REF PAIN1069B by Medline Industries Northfield, citing the connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0513-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-16 |
| Published | 2024-12-04 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
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
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
Identifiers
| code_info | Codes: 1) PAIN1069B UDI-DI: 10889942757381 (each) 40889942757382 (case), Lot Numbers: 22GLA433, 23CLA257; 2) PAIN1941…Codes: 1) PAIN1069B UDI-DI: 10889942757381 (each) 40889942757382 (case), Lot Numbers: 22GLA433, 23CLA257; 2) PAIN1941 UDI-DI: 10195327365417 (each) 40195327365418(case), Lot Numbers: 23ELB081; 3) PAIN9023 UDI-DI: 10889942448715(each) 40889942448716 (case), Lot Numbers: 22GLA470, 22ILA287; 4) PAIN1281 UDI-DI: 10888277748408(each) 40888277748409(case), Lot Numbers: 22FLA647; 5) PAIN9024 UDI-DI: 10889942448708(each) 40889942448709(case), Lot Numbers: 22FLA675, 22GLA241, 22HLB225, 22ILA288 |
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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-0513-2025%22
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