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
Lubricant, patient - Product Code KMJ
원인
Product was not sterilized. product was shipped to distribution centers instead of the sterilization facility due to an operations error by a 3rd party shipping company.
조치
Medline Industries sent a recall notification letters dated December 12, 2016 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to quarantine any affected product on hand and return product to Medline Industries for credit. Distributors were instructed to notify their customers and have them return affected product as well. For questions contact 866-359-1704.
Worldwide Distribution - US Nationwide in the states of AL, FL, GA, IA, IL, IN LA, MI, PA, TX, WI, and the country of Canada
제품 설명
Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL OZ (59 ml). || Product Usage: || For medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices. Single use only. Sterile if unopened, undamaged package.