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U.S. Department of Health and Human Services

Class 1 Device Recall Guardian II and Guardian II NC Hemostasis Valve

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 Class 1 Device Recall Guardian II and Guardian II NC Hemostasis Valve see related information
Date Posted March 20, 2013
Recall Status1 Terminated on August 05, 2013
Recall Number Z-0955-2013
Recall Event ID 64511
510(K)Number K092711  K101113  K122301 
Product Classification Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass - Product Code DTL
Product Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, used in cardiopulmonary bypass.

Model numbers: FH101, FH101-T, FH101-25, FH101-50, 8210, 8211, FH102, FH102-T, FH102-25, FH102-50, 8215, 8216, 8241, 8242, 8244, 8272 and 8274.

Vascular Solutions Zerusa Limited.

Intended to maintain hemostasis during the use of diagnostic/interventional devices during diagnostic/interventional procedures.

Code Information 49
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27295
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29453
27401
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27658
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28245
28818
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29131
29131
29453
29453
30238
30580
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27403
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Recalling Firm/
Manufacturer
Vascular Solutions, Inc.
6464 Sycamore Ct N
Maple Grove MN 55369-6032
For Additional Information Contact
763-656-4300
Manufacturer Reason
for Recall
Risk that air may be introduced into the device which may lead to an air embolism.
FDA Determined
Cause 2
Vendor change control
Action Consignees were sent a Vascular Solutions "Urgent Medical Device Recall" letter dated February 28, 2013. The letter described the problem and the product involved in the recall. In addition, consignees were advised to identify the location of and immediately remove the recalled product from their inventory and secure it. Consignees were requested to complete and return the VSI Account Inventory Form. The letter also stated that VSI Customer Service would contact customers within 1-2 business days after receiving the completed VSI Account Inventory Form. All returned affected product will be replaced upon receipt. Customers are to contact their local Sales Representative if they have any questions or concerns regarding this recall.
Quantity in Commerce 79,869
Distribution Worldwide Distribution -- USA, including the states of AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, IL IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NJ, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT , VT, VA, WA, WV, and WI, and countries of GREECE, DENMARK, AUSTRIA, UNITED KINGDOM, SWITZERLAND, IRELAND, INDIA, TURKEY, POLAND, HUNGARY, ITALY, EGYPT, KOREA, PORTUGAL HONG KONG, GERMANY, SPAIN, MEXICO, SWEDEN, NORWAY SLOVENIA, NETHERLANDS, and BELGIUM.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DTL and Original Applicant = VASCULAR SOLUTIONS ZERUSA LTD.
510(K)s with Product Code = DTL and Original Applicant = ZERUSA LIMITED
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