Z-1529-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 12, 2021
- Initiation Date
- April 6, 2021
- Termination Date
- December 29, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 616 units
Product 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.
Reason for Recall
The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field.
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.
Code Information
Lot: LCI1091, LCI1092, LCI1093, LCI1094, LCI1095, LCI1096, LCI1097, LCI1098, LCI1099