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U.S. Department of Health and Human Services

Class 2 Device Recall Neptune Plus, hemostasis pad

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  Class 2 Device Recall Neptune Plus, hemostasis pad see related information
Date Initiated by Firm October 14, 2015
Create Date November 18, 2015
Recall Status1 Terminated 3 on October 24, 2016
Recall Number Z-0293-2016
Recall Event ID 72451
510(K)Number K071442  
Product Classification hemostasis pad - Product Code FRO
Product Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath removal, Part number 8870-03
Code Information Lot Numbers:  AGR554; AGR554\20; AGR554\24; AGR554/24; AGR570\28; AGR570/43; AGR744124; AGR744137.
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		 The IFU of the Neptune Plus Pads, does not match that submitted in the original 510k. Need to remove: for haemostasis following needle/sheath removal
FDA Determined
Cause 2		 Labeling False and Misleading
Action TZ Medical Inc. began sending the Urgent: Medical Device Correction 8870-03 Neptune Plus letter, dated 10-7-2015, to consignees in October 2015. The firm is notifying all users of Neptune Plus wound dressing to a correction to the Instructions for Use (IFU). Consignees should discard the IFU in your current inventory and replace with new IFU. Consignees with questions should call TZ Medical Inc. at (503) 639-0282.
Quantity in Commerce 32,170 units
Distribution US nationwide distribution.
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 = SPECIALTY FIBRES AND MATERIALS LTD.
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