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Class 2 Device Recall Vascular Clip |
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Date Initiated by Firm |
January 31, 2020 |
Create Date |
May 15, 2020 |
Recall Status1 |
Terminated 3 on April 20, 2022 |
Recall Number |
Z-2037-2020 |
Recall Event ID |
85421 |
510(K)Number |
K883909
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Product Classification |
Clip, vascular - Product Code DSS
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Product |
STEALTH SPRING CLIP 6mm latis (1/4 Force). Non-Sterile, REF/UDI::A1702/(01)10607915110649 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery. |
Code Information |
LOT # 1360163, Manufacture Date July 3, 2019; Expiration Date July 3, 2024 |
Recalling Firm/ Manufacturer |
Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa Margarita CA 92688-2650
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For Additional Information Contact |
Ms. Lauren Contursi 949-713-8767
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Manufacturer Reason for Recall |
Failure of cardiovascular clips to provide sufficient occlusion of the vessel.
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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 |
750 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
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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.
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510(K) Database |
510(K)s with Product Code = DSS and Original Applicant = APPLIED VASCULAR DEVICES, INC.
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