Z-1529-2021 Class II Terminated
FDA device recall Z-1529-2021 was initiated by LeMaitre Vascular, Inc. on April 6, 2021 and is designated Class II. Reason for recall: The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field. The recall status is terminated (terminated December 29, 2022). Affected quantity: 616 units.
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