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.
Convatec inc. is recalling flexi-seal fms control kit since it does not have a 510k. in addition, an internal assessment of product performance, including a review of customer
feedback, has confirmed that flexi-seal control is not meeting expectations or those of customers. specifically, the auto-valve feature that is unique to the flexi-seal control
has not been consistently performing relative.
조치
Convatec Inc. sent an Urgent Voluntary Medical Device Recall letter dated April 29, 2014 via UPS. The letter identified the affected product, problem and actions to be taken. Customers are asked to immediately stop distributing and quarantine all recalled lots. Affected products must be returned to Distributor. Contact your Distributor for shipping instruction. Customers should completed the attached return response form and return it to the address on the response form. Questions can be directed to Gregory Kowzun at (336) 547-3710. Convatec issued a press release on 7/3/2014.
Convatec Flexi Seal Control Fecal Management System Rx Only || REF 411107 || Product Usage:For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medications as prescribed by a physician.