![]() ![]() ![]() While processing their returns, please maintain a copy of this notice with the product subject to this recall and keep a copy for your records. Keep the letter visibly posted for awareness until all product subject to this recall has been returned to Stericycle. Have completed the Business Reply Form (BRF) confirming receipt within 3 business days of receipt of the firm's letter, even if they do not have product subject to this recall. Please consider including a copy of this recall letter when communicating. If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return. Remove the product subject to this voluntary recall and communicate the issue to relevant operating room or materials management personnel, or anyone else in their facility who needs to be informed. Health care facilities, distributors, and other customers must:Įxamine their inventory immediately to determine if they have product subject to this recall on hand and quarantine such product(s). On October 3, 2019, Ethicon sent a letter to customers who purchased the affected staplers and provided instructions. Surgeons who have performed or will perform surgeries using staplers for internal use Patients who have had or may undergo surgery involving staplers for internal use As of October 3, 2019, 7 serious injuries and 1 death had been reported to Ethicon for affected product codes. If a problem with the staple line is not recognized or is not adequately addressed, there is a potential risk of prolonged surgery, postoperative connection (anastomotic) leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death. The staplers can be used in open or in minimally-invasive surgical procedures, including gynecologic, urologic, thoracic, pediatric, and general surgeries.Įthicon is recalling these devices because some devices may contain an out of specification component within the jaw of the device, which could lead to malformed staples. The Echelon Flex Endopath staplers are sterile, single patient use devices that cut and staple internal tissue. Lot Numbers: See specific lot numbers hereĭistribution Dates: Aug– September 26, 2019 Product Codes: EC60A, PCEE60A, PLEE60A, PSEE60A Use of these devices may cause serious injuries or death.ĮCHELON Flex 60 Endopath Stapler, Articulating Endoscopic Linear Cutter (EC60A)ĮCHELON Flex 60 Powered Plus Compact Articulating Endoscopic Linear Cutter (PCEE60A)ĮCHELON Flex 60 Powered Plus Articulating Endoscopic Linear Cutter, 44cm Shaft Length (PLEE60A)ĮCHELON Flex 60 Powered Plus Articulating Endoscopic Linear Cutter, 34cm Shaft Length (PSEE60A) The FDA has identified this as a Class I recall, the most serious type of recall.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |