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
Suture, surgical, absorbable, polydioxanone - Product Code NEW
원인
Three (3) lots were distributed with the incorrect expiry date on the label. the lots
were labeled with an expiry date of five (5) years from date of manufacture instead
of the correct expiry date of two (2) years from date of manufacture.
조치
On January 10, 2018 an URGENT MEDICAL DEVICE LETTER for removal was issued to customers requesting that all affected personnel to discontinue use or distribution of the recalled product. The following actions being required:
1. Examine inventory and quarantine all affected product
2. Communicate this recall notice to all affected personnel at facility, or other affected facilities.
3. Complete the business reply form attached to the recall letter.
4. Keep the recall notice posted visibly at facility and maintain a copy with your records
5. Return unused product to recalling firm by April 13, 2018.
For further assistance contact 1-855-215-5039.