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
Tourniquet, pneumatic - Product Code KCY
원인
Sterilmed, inc. is voluntarily recalling all unexpired reprocessed tourniquet cuffs. sterilmed cannot assure the sterility of all units in the recalled lots. the introduction of non-sterile product into a sterile operative field raises the risk of potential infection. sterilmed has not received any reports of adverse events for this issue.
조치
Consignees were sent a Sterilmed "Urgent Medical Device Recall: letter dated November 13, 2015. The letter was addressed to Materials Manager, Risk Manager and Operating Room Director. The letter described the product affected, the description of the problem and the Actions Required. Requested consignees to quarantine and return affected product and to complete and return the
Business Reply Form. For questions contact Sterilmed's Customer Care Team at 888-541-0078.