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
Mask, oxygen - Product Code BYG
원인
The case label correctly states partial rebreather but the insert label incorrectly states non-rebreather.
조치
Salter Labs sent a Medical Device Recall letter dated June 25, 2014 to all affected customers. The letter identified the affected product, problems and actions to be taken. Customers are instructed to complete the attached Return Response Form and return it to Salter as soon as possible. Customers are instructed to send completed form to Salter by either Fax (800) 628-4690, attn: Sarah Velasquez, email to SVelasquez@us.salterlabs.com, or mail to Salter Labs, attn: Sarah Velasquez, 100 W. Sycamore Rd. Arvin, CA 93203.