U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Wire, guide, catheter - Product Code DQX
원인
Label does not state that the product is heparin-coated.
조치
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