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.
- Company
- Lemaitre Vascular, Inc.
- Recall Initiated
- April 6, 2021
- Terminated
- December 29, 2022
- Recall Number
- Z-1529-2021
- Quantity
- 616 units
- Firm Location
- Burlington, MA
Reason for Recall
The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field.
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.
Lot / Code Info
Lot: LCI1091, LCI1092, LCI1093, LCI1094, LCI1095, LCI1096, LCI1097, LCI1098, LCI1099
Root Cause
Process control
Action Taken
On 04/01/2021, LeMaitre issued an Urgent Medical Device Removal notice via letter informing customers that particulate contamination has been detected from the packaging foam with these devices.
More recalls by Lemaitre Vascular, Inc.
TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38, 1651-44, 1651-48,...
May 12, 2025
Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56
May 12, 2025