CooperSurgical Gets 483 Over Cannula Processing Issues
Women's healthcare device manufacturer CooperSurgical received a Form 483 for failure to initiate corrective action for a process failure associated with its Blunt Hurd Cannula-Blunt Tip 10mm with 5mm Reducer.
The Sept. 23, 2014, form says two lots of the devices were distributed with the wrong instructions for use. A portion of one lot was distributed to a U.S. consignee in August 2013. The company voluntarily recalled the two lots a month later.
The company also did not try to obtain information to evaluate complaints received by its service and repair department. The 483 cites several complaints involving the UMI II backloadable, where the repair form did not document patient involvement or harm and type of procedure performed by the physician.
The form was issued after a Sept. 16 inspection of the company's Stafford, Texas, facility.
CooperSurgical did not respond to a request for comment by press time. Read the form at www.fdanews.com/02-26-15-Coopersurgical.pdf.