|
Class 2 Device Recall Bone Marrow Biopsy Needle |
![see related information](../images/related-info.gif) |
Date Initiated by Firm |
June 18, 2015 |
Date Posted |
July 21, 2015 |
Recall Status1 |
Terminated 3 on June 23, 2016 |
Recall Number |
Z-2189-2015 |
Recall Event ID |
71533 |
510(K)Number |
K980196
|
Product Classification |
Instrument, biopsy - Product Code KNW
|
Product |
T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL; T-Lok Bone Marrow Biopsy Needle 11G x 4 Ext Can, Part Number DBMNJ1104TL; Bone Marrow Biopsy Needle 13G x 4, Part Number DBMNJ1304 |
Code Information |
Lot Numbers: 11088295, 11088596, 11088597, 11089105, 11089366, 11094182, 11094681, 11094912, 11095381, 11095844, 11095845, 11095951, 11096558, 11097278, 11097504, 11098024, 11098647, 11099173 |
Recalling Firm/ Manufacturer |
Argon Medical Devices, Inc 1445 Flat Creek Rd Athens TX 75751-5002
|
For Additional Information Contact |
Rebecca Ellis 972-403-0749
|
Manufacturer Reason for Recall |
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 |
Packaging process control |
Action |
The recalling firm's sales force was notified of the recall on 6/17/15. The recalling firm will begin to send out Urgent Medical Device Recall letters by registered mail to affected customers on 6/18/15. Customers are instructed to inspect and quarantine and return any affected product and complete the Recal Response Form. |
Quantity in Commerce |
10290 units |
Distribution |
US |
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.
|
|
|
|