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
Labeled as j tip but may be straight tip.
조치
The firm notified all user/hospital accounts via a 7/16/2002 letter sent via FEDEX along with a response form. Accounts were to return any recalled product.
Product was distributed to 7 hospital accounts in FL, KS, NH, IA, PA, MI AND CA.
제품 설명
Scimed ChoICE PT ''J'' Tip 182 cm Guide Wire, a single use, sterile (EO), device packaged in a carrier tube, which is held in a coil by plastic clips. The carrier tube assembly of the guide wire is sealed into a pouch. The pouch assembies are packaged in a five-pack product box.