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 - Product Code GAM
원인
Package defect compromised the integrity of the primary seal, which could lead to premature suture degradation and/or impair the sterile barrier of the product.
조치
Letters were sent to distributors, Director of Surgery, Director of Risk Management, Director of Materials Management and Director of Operating Room on August 11, 2008, requesting that all affected lot numbers of Vicryl Rapide be discontinued immediately from sale and/or use. A separate correspondence was sent to hospitals. Letters to Director of Surgery, Director of Risk Management, Director of Materials Management and Director of Operating Rooms were advised of the recall and asked to discontinue use of any of the affected lot codes of sutures. Return and credit instructions were provided to the Director of Material Management. Contact Ethicon, Inc. at 1-908-218-2553 for assistance.
Worldwide: US and Canada OUS: Australia, New Zealand and Indonesia.
제품 설명
VICRYL RAPIDE (polyglactin 910) Braided Coated Synthetic Absorbable Suture, Undyed, Non-USP. || Ethicon, Inc., a Johnson & Johnson Co.,Somerville, NJ 08876 || The product is used for Soft Tissue approximation.