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
|
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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.
|
510(K) Database |
510(K)s with Product Code = FRO and Original Applicant = SPECIALTY FIBRES AND MATERIALS LTD.
|