FDA Device recall Z-1529-2021
LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product Usage: intended to be used to perfuse contrast medias in…
- FDA Device
- Class II
- terminated
- Published 2021-05-12
On 2021-05-12 the FDA classified a Class II recall of LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product Usage: intended to be used to perfuse contrast medias in… by Lemaitre Vascular, citing the firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1529-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-04-06 |
| Published | 2021-05-12 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Lemaitre Vascular |
| Distribution | US |
Product
LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product Usage: intended to be used to perfuse contrast medias into the vessels for angiographic procedures, Catalog #: 4100-00.
Reason
The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field.
Identifiers
| code_info | Lot: LCI1091, LCI1092, LCI1093, LCI1094, LCI1095, LCI1096, LCI1097, LCI1098, LCI1099 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1529-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.