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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 Clipsee related information
Date Initiated by FirmJanuary 31, 2020
Create DateMay 15, 2020
Recall Status1 Terminated 3 on April 20, 2022
Recall NumberZ-2037-2020
Recall Event ID 85421
510(K)NumberK883909 
Product Classification Clip, vascular - Product Code DSS
ProductSTEALTH 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
FEI Number 2027111
Recalling Firm/
Manufacturer		 Applied Medical Resources Corp
22872 Avenida Empresa
Rancho Santa Margarita CA 92688-2650
For Additional Information ContactMs. 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
ActionOn 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 Commerce750 units
DistributionWorldwide 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 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 = DSS
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