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, nonabsorbable, synthetic, polyamide - Product Code GAR
원인
Aesculap inc. (aic (usa)) has initiated a voluntary recall of dafilon black 10/0 (0.2) 15 cm drm4 non-sterile non-absorbable polyamide surgical suture due to a labeling issue. box labels do state non-sterile; however there is an additional label that is affixed on the box that states the product is sterile.
조치
A correction and removal notification, dated June 13, 2014, was sent to end users, sales reps, and distributors which described the product, problem, and actions to be taken.
Dafilon Suture Black 10/0 (0.2) 15 cm DRM4 NS, non-sterile, non-absorbable polyamide Surgical Suture, additional label affixed on the box states the product is sterile, packaged in a cassette holding 12 sutures