Date Initiated by Firm |
January 18, 2017 |
Date Posted |
February 13, 2017 |
Recall Status1 |
Terminated 3 on May 17, 2017 |
Recall Number |
Z-1195-2017 |
Recall Event ID |
76292 |
510(K)Number |
K980196
|
Product Classification |
Instrument, biopsy - Product Code KNW
|
Product |
T-LOK BONE MARROW BIOPSY NEEDLE 8G x 4 EXT CAN; T-LOK BONE MARROW BIOPSY NEEDLE 11G x 4 EXT CAN
Intended for the purpose of harvesting bone and/or bone marrow specimens |
Code Information |
lots: 11157523, 11158179, 11158180, 11159101, 11159729 |
Recalling Firm/ Manufacturer |
Argon Medical Devices, Inc 1445 Flat Creek Rd Athens TX 75751-5002
|
For Additional Information Contact |
Rebecca Ellis 903-403-0749
|
Manufacturer Reason for Recall |
The recalling firm received a complaint from one of their customers of a potential defect in the forming of
the primary package of the blister that may compromise the sterility of the product inside the tray.
|
FDA Determined Cause 2 |
Equipment maintenance |
Action |
Argon Medical Devices, Inc. is sending an Urgent Product Recall Notice letter dated January 17, 2017, by registered mail to all affected customers. Customers were asked to determine if their inventory shows the package defect and discontinue use of the device and promptly return the affected product. For questions regarding this recall call 903-403-0749. |
Quantity in Commerce |
772 boxes |
Distribution |
Worldwide Distribution - US (nationwide) and Internationally to Switzerland, Canada, Australia, New Zealand, Ecuador, Colombia, and Japan. |
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 = KNW and Original Applicant = MEDICAL DEVICE TECHNOLOGIES, INC.
|