Recall Z-1529-2021 ยท DXT Injector And Syringe, Angiographic
LeMaitre Vascular, Inc.
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.
| Date | Apr 6, 2021 |
| Status | Terminated |
| Reason | The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 616 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K973334 | OZ POWER SYRINGE Cardiovascular Innovations, Apr 3, 1998 |