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U.S. Department of Health and Human Services

Class 2 Device Recall Vascular Clip

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  Class 2 Device Recall Vascular Clip see related information
Date Initiated by Firm January 31, 2020
Create Date May 15, 2020
Recall Status1 Terminated 3 on April 20, 2022
Recall Number Z-2034-2020
Recall Event ID 85421
510(K)Number K883909  
Product Classification Clip, vascular - Product Code DSS
Product STEALTH SPRING CLIP 6mm latis (1/2 Force). REF/UDI::A1601/(01)00607915110567 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.
Code Information LOT # 1359929, Manufacture Date June 28, 2019; Expiration Date June 26, 2024
Recalling Firm/
Manufacturer		 Applied Medical Resources Corp
22872 Avenida Empresa
Rancho Santa Margarita CA 92688-2650
For Additional Information Contact Ms. Lauren Contursi
949-713-8767
Manufacturer Reason
for Recall		 Failure of cardiovascular clips to provide sufficient occlusion of the vessel.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On 01/31/2020, Customer Notification Letter was sent to all consignees/ distributors requesting them to return the affected devices to the recalling firm.
Quantity in Commerce 2240 units
Distribution Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KY, MA, MI, MO, NC, NE, NJ, NY, OK, PA, TN, TX, UT, VA. WA and WI. The countries of Austria, Australia, Canada, Switzerland, Germany, Spain, Finland, France, Italy, Japan, Mexico, and Netherlands.
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 = DSS and Original Applicant = APPLIED VASCULAR DEVICES, INC.
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