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U.S. Department of Health and Human Services

Class 2 Device Recall LeverEdge Contrast Injector

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  Class 2 Device Recall LeverEdge Contrast Injector see related information
Date Initiated by Firm April 06, 2021
Create Date May 04, 2021
Recall Status1 Terminated 3 on December 29, 2022
Recall Number Z-1529-2021
Recall Event ID 87689
510(K)Number K973334  
Product Classification Injector and syringe, angiographic - Product Code DXT
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.
Code Information Lot: LCI1091, LCI1092, LCI1093, LCI1094, LCI1095, LCI1096, LCI1097, LCI1098, LCI1099
Recalling Firm/
Manufacturer		 LeMaitre Vascular, Inc.
63 2nd Ave
Burlington MA 01803-4413
For Additional Information Contact Laurie Churchill
781-221-2266
Manufacturer Reason
for Recall		 The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field.
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DXT and Original Applicant = CARDIOVASCULAR INNOVATIONS
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