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
ophthalmic irrigation and aspiration - Product Code KYG
원인
Plastic shavings are coming from the product
handle during irrigation. use of this product may leave plastic shavings in the patient's eyes.
조치
An April 9, 2007, notification of the recall will be sent to distributors and users. They are requested to notify down to the user (physician) level. Included in the Recall
Notification Letter are instructions: "In addition, if you may have further distributed this product,
please identify your customers and notify them at once of this
product recall. Your notification to your customers may be
enhanced by induding a copy of this recall notification letter.
This recall should be carried out to the user level. Your
assistance is appreciated and necessary to prevent any
inconvenience."
Worldwide, including USA, United Kingdom, Canada, Spain, Turkey, Kuwait, Colombia, Italy, Greece, Australia, Switzerland, South Africa, Germany, Portugal, and France.
제품 설명
Disposable Bimanuals Irrigation and Aspiration Handpiece Set: Item #1719 Disposable Bimanuals Irrigation/Aspiration Set 19 Gauge, Dual Port; Item #1719-A - Disposable Bimanual Aspiration Handpiece 19g; Item #1719-I Disposable Bimanuals Irrigation/Aspiration Set, 19g, Open End; Item #1719-S Disposable Bimanuals Irrigation/Aspiration Set, 19g, Dual Port, Smooth. For use in cataract surgical procedures.