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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 27403
28048
30238
28245
29453
29835
27403
28247
30126
27294
31020
31020
28050
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28247
29836
27660
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29453
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28245
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27294
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29131
29131
29453
29835
30238
30238
27658
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29836
28050
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28818
29454
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27658
28041
28048
28048
28245
28245
28818
29131
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29131
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27294
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28246
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27658
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29835
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28245
28247
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29835
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29453
27295
27295
27403
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28247
27401
28245
30238
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28049
28819
27660
30579
27295
27295
27295
27403
27403
27660
28043
28247
28247
28247
28820
28820
29836
30126
30126
30126
30579
30582
28041
28818
29453
30580
27660
30579
27660
28247
27295
27295
27660
28247
28247
28820
30126
30579
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29131
29835
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29134
29134
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28041
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28818
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28245
29131
27401
27658
28041
28041
28048
28245
28818
29131
29453
29453
30238
30238
28820
27401
27295
27403
27660
28043
28247
28820
29836
30582
28245
29835
28246
28246
28819
28246
27401
28048
28245
27401
27401
27401
27658
27658
27658
27658
27658
28041
28041
28041
28041
28048
28048
28048
28245
28245
28245
28245
28246
28246
28818
28818
28818
28818
28818
29131
29131
29131
29453
29453
29453
29453
29835
29835
29835
30238
30238
30238
30580
30580
30580
28245
29453
28041
28818
29131
28042
28246
27294
27402
27659
27659
28049
28246
28246
28246
28819
29132
29132
30578
30578
27401
28041
28245
28818
29835, and
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Recalling Firm/
Manufacturer
Vascular Solutions, Inc.
6464 Sycamore Ct N
Maple Grove MN 55369-6032
763-656-4300
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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