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Class 1 Device Recall Guardian II Hemostasis Valve |
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Date Initiated by Firm |
March 04, 2016 |
Date Posted |
April 07, 2016 |
Recall Status1 |
Terminated 3 on October 19, 2016 |
Recall Number |
Z-1275-2016 |
Recall Event ID |
73553 |
510(K)Number |
K122301
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Product Classification |
Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass - Product Code DTL
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Product |
Guardian II Hemostasis Valve, models 8210 and 8211. The following models are only available Outside the US: FH101, FH101-T, FH101-25, and FH101-50.
Product Usage: The Guardian hemostasis valves are designed to be used as conduits when interventional devices with diameters up to 8 F are inserted into the human vascular system. The devices have two seals: the low-pressure seal, and the high-pressure seal. Closure of the high-pressure seal, which is achieved when the nut can no longer rotate, secures the diagnostic/interventional device in position within the vasculature and allows for pressure injections up to 600 psi. |
Code Information |
Lot numbers: 41776, 41777, 41874, 42108, 42525, 581766, 581767, 583285, and 583286. |
Recalling Firm/ Manufacturer |
Vascular Solutions, Inc. 6464 Sycamore Ct N Maple Grove MN 55369-6032
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For Additional Information Contact |
763-656-4300
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Manufacturer Reason for Recall |
Vascular Solutions became aware of a potential problem with the click version of the Guardian II hemostasis valves. The low pressure seal may not close properly, which may allow air to be introduced into the device and may lead to risk of an air embolism.
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FDA Determined Cause 2 |
Employee error |
Action |
Consignees were sent on 3/4/2016 via first class mail a Vascular Solutions "Urgent Medical Device Recall" letter dated March 3, 2016. The letter described the problem and the product involved in the recall. It included the "Immediate Action Required of Customer / User" which instructed the customer to identify the product, remove it from inventory, place it in a secure area, and complete and return the VSI Account Inventory Form to the Customer Service Department. |
Quantity in Commerce |
5283 |
Distribution |
Nationwide Distribution in the states of AL, AR, CA, CO, DE, FL, GA, ID, IL IN, IA,KY, LA, MD, MA, MI, MO, NE,NV, NH, NY, NC, OH, PA, SD, TN, TX, UT, VA, WA, and WV.
OUS: Ireland |
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 = DTL and Original Applicant = VASCULAR SOLUTIONS ZERUSA LTD.
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