LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer… — Class II medical device recall Z-1529-2021
Terminated recall by LeMaitre Vascular, Inc., reported 2021-05-12, distributed nationwide. The firm received a complaint regarding particulate found in the packaging foam that could contaminate the ste
| Recall number | Z-1529-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LeMaitre Vascular, Inc., Burlington, MA, United States |
| Recall initiated | 2021-04-06 |
| Classified | 2021-05-04 |
| Reported by FDA | 2021-05-12 |
| Terminated | 2022-12-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, BS, DE, ES, FR, HK |
| Quantity | 616 units |
| Reason classes | sterility, specification failure |
| Lot numbers | LCI1091, LCI1092, LCI1093, LCI1094, LCI1095, LCI1096, LCI1097, LCI1098, LCI1099 |
| Model numbers | 4100-00 |
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 for recall
The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field.
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-1529-2021. 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.