LeMaitre Vascular, Inc. Recall 87689
Description: 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.
LeMaitre Vascular, Inc. Recall 87689 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1529-2021 |
| Event ID | 87689 |
| Event Description | 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. |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AL, CA, FL, IL, IN, KY, MA, MO, NY, OH, TN, TX and the countries of Bahamas, Belgium, France, Germany, Hong Kong, Spain. |
| Quantity | 616 units |
| Recall Reason | The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field. |
| Device Classification | 20210512 |
| Device Code Info | Lot: LCI1091, LCI1092, LCI1093, LCI1094, LCI1095, LCI1096, LCI1097, LCI1098, LCI1099 |
| Center Classification Date | 20210504 |
| Recall Initiation Date | 20210406 |
| Recalling Firm | LeMaitre Vascular, Inc. |
| Initial Notification | Letter |
| Similar To |