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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 Injectorsee related information
Date Initiated by FirmApril 06, 2021
Create DateMay 04, 2021
Recall Status1 Terminated 3 on December 29, 2022
Recall NumberZ-1529-2021
Recall Event ID 87689
510(K)NumberK973334 
Product Classification Injector and syringe, angiographic - Product Code DXT
ProductLeverEdge 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 ContactLaurie 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
ActionOn 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 Commerce616 units
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = DXT
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