|
Class 2 Device Recall PC Holdex |
|
Date Initiated by Firm |
August 05, 2008 |
Date Posted |
September 30, 2008 |
Recall Status1 |
Terminated 3 on July 25, 2012 |
Recall Number |
Z-2198-2008 |
Recall Event ID |
49367 |
510(K)Number |
K980768
|
Product Classification |
Needle - Product Code FMI
|
Product |
Plastic Cannula Holdex¿ Tube Holder, Item number: 450216. It is intended for use in routine specimen withdrawal from specimen collection bags or bottles through needleless cannula ports. |
Code Information |
Lot#: A030804 |
Recalling Firm/ Manufacturer |
Greiner Bio-One North America, Inc. 4238 Capital Dr Monroe NC 28110-7681
|
For Additional Information Contact |
Manfred Pillichshammer 704-261-7800
|
Manufacturer Reason for Recall |
At removal of the tube from the holder the needle may dislodge and become stuck in the tube stopper with the blunt end of the needle facing out.
|
FDA Determined Cause 2 |
Process design |
Action |
Consignees were notified by letter on 08/06/2008. Letters to Distributors instructed them to stop distribution of the affected product immediately and to hold any product of the lots they may have pending returned to Greiner bio-one. The were instructed to provide Greiner bio-one with a list of their customers who may have received the affected lot so that they can contact them. A Product Disposition form was included to be completed and returned to Greiner bio-one. Contact Greiner Bio-One North America, Inc. at 1-888-286-3883 for assistance. |
Quantity in Commerce |
150,000 pcs |
Distribution |
AL, FL, IN, KS, KY, MO, MN, NC, OH, PA, TN, TX, UT, VA, WI 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 = FMI and Original Applicant = GREINER MEDITECH, INC.
|
|
|
|