Date Initiated by Firm |
October 13, 2017 |
Create Date |
March 09, 2018 |
Recall Status1 |
Terminated 3 on October 23, 2019 |
Recall Number |
Z-0950-2018 |
Recall Event ID |
79195 |
Product Classification |
Wire, guide, catheter - Product Code DQX
|
Product |
Amplatz Ultra Stiff Wire Guide |
Code Information |
Catalog # THSF / ASG-BH Affected lot codes range from: 3730001 - 6164916 F3729969 - F4922979 NS4928020 - NS6203182 Affected lot codes range from: 3733552 - 6175191 F3729974 - F4923948 NS4927345 - NS6177894 |
Recalling Firm/ Manufacturer |
Cook Inc. 750 N Daniels Way Bloomington IN 47404-9120
|
For Additional Information Contact |
Cook Medical Customer Relations Department 812-339-2235
|
Manufacturer Reason for Recall |
Label does not state that the product is heparin-coated.
|
FDA Determined Cause 2 |
Labeling Change Control |
Action |
On October 31, 2017 an URGENT MEDICAL DEVICE CORRECTION was issued to customers requesting the following, including a corrective action:
Step 1:
Determine if your product is
included in the affected lot
ranges by comparing your lot
number to the listing
provided.
" If your product is not
affected, complete the
Acknowledgement and
Receipt Form.
" If your product is affected,
proceed to Step 2.
Step 2:
Remove a Heparin Coated
label from the label sheet
provided and apply to the top
right corner of your affected
unit.
o If you need additional
labels, please contact
Stericycle at
855.215.4967.
If you would like assistance,
representatives are available to support
you. To request assistance, please
contact Stericycle at 855.215.4967 |
Quantity in Commerce |
12,462 |
Distribution |
Nationally |
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.
|