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U.S. Department of Health and Human Services

Class 2 Device Recall Neptune Plus (Hemostatic Pad)

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  Class 2 Device Recall Neptune Plus (Hemostatic Pad) see related information
Date Initiated by Firm July 07, 2016
Create Date October 21, 2016
Recall Status1 Terminated 3 on October 28, 2016
Recall Number Z-0298-2017
Recall Event ID 74809
510(K)Number K040208  
Product Classification Dressing, wound, drug - Product Code FRO
Product Neptune Plus (Hemostatic Pad), Part Numbers: 8870-03
Neptune Pad is used to promote the rapid control of bleeding and provide hemostasis for lacerations, abrasions, vascular access sites and following surgical incision. It can be used to achieve hemostasis at the skin surface for arterial/venous catheterization/tubes, needle puncture, hemodialysis and in patients on anticoagulation therapy
Code Information Lot R970249
Recalling Firm/
Manufacturer		 TZ Medical, Inc.
17750 SW Upper Boones Ferry Rd Ste 150
Portland OR 97224-7086
For Additional Information Contact John Lubisich
503-639-0282
Manufacturer Reason
for Recall		 Neptune Plus was mis-labeled and included the statement WITH ANTIMICROBIAL BARRIER. This statement should not appear on label.
FDA Determined
Cause 2		 Labeling Change Control
Action TZ Medical notified their consignees by telephone on July 7, 2016. Customers with the boxes with the identified statement, "With Antimicrobial barrier, the firm plans to overlabel the statement on-site. If customer does not have the mis-labeled box upon contact, no action is planned. The firm also determined to overlabel devices on-hand. For questions regarding this recall call 503-639-0282.
Quantity in Commerce 1410 (141 boxes of 10)
Distribution Nationwide Distribution to AL, CA, FL, GA, IL, IN, KY, MO, MS, NC, NV, NY, PA, SC, TN, TX, and WV.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = FRO and Original Applicant = TZ MEDICAL, INC.
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