Device 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.
Z-1529-2021
Product summary
- Event
- Event 87689
- Status
- Terminated
- Classification
- Class II
- Quantity
- 616 units
- Official record key
device-enforcement:Z-1529-2021
Official wording
Reason: The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field.
Code information: Lot: LCI1091, LCI1092, LCI1093, LCI1094, LCI1095, LCI1096, LCI1097, LCI1098, LCI1099
Distribution pattern: 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.
Derived failure modes
-
Foreign material or chemical contamination
particulate