Events

MERSILENE NON-ABSORBABLE POLYESTER FIBER SUTURE 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    47915
  • 사례 위험등급
    II
  • 사례 시작날짜
    2016-08-02
  • 사례 국가
    Canada
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • 데이터 추가 비고
  • 원인
    Ethicon has initiated a worldwide medical device correction (notification) for unexpired lots of select ethicon mersilene tape (also referred to as mersilene polyester fiber strip or mersilene fiber ligature) products as it was discovered that a group of mersilene tape product codes are being supplied with an incorrect instructions for use (ifu) insert. the product codes subject to this correction are being supplied with a mersilene suture ifu. corrective actions are currently being implemented to include the correct mersilene tape ifu with future shipments of mersilene tape products. this notification serves as an immediate correction to provide customers with the correct mersilene tape ifu.

Device

MERSILENE NON-ABSORBABLE POLYESTER FIBER SUTURE
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: D7164 (Lot serial: All Unexpired Lots); Model Catalog: D8113 (Lot serial: All Unexpired Lots); Model Catalog: D8062 (Lot serial: All Unexpired Lots); Model Catalog: RS20 (Lot serial: All Unexpired Lots); Model Catalog: RS21 (Lot serial: All Unexpired Lots); Model Catalog: RS22 (Lot serial: All Unexpired Lots); Model Catalog: RS23 (Lot serial: All Unexpired Lots)
  • 제품 설명
    MERSILENE NON-ABSORBABLE POLYESTER FIBER SUTURE;MERSILENE WOVEN TAPE;MERSILENE NON ABSORBABLE POLYESTER FIBER SUTURE
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.