Medtronic announced today that a previously communicated global voluntary recall to address an issue with certain lots of its Trellis-6 and Trellis-8 peripheral infusion systems has now been classified as a Class 1 Recall by the U.S. Food and Drug Administration. Customers were previously notified by Covidien of the recall on December 15, 2014.
The physician using the device may deflate the balloons in the incorrect order. If this happens, there is a potential for blood clots to dislodge and move into the lungs.
Problems in the manufacturing process may lead to unexpected need to stop the ventilator and transfer the patient to another ventilator.
Ventilator may stop working after the air and oxygen gas supply lines are disconnected and then reconnected. This can lead to serious health problems or death.
Covidien today announced that it has notified customers of a voluntary Field Safety Alert for certain Medi-Trace Cadence and Kendall Multi-function Defibrillation Electrodes due to a connector compatibility issue with Philips FR3 and FRx Defibrillators.
Damage to the jacket can result in embolization of polymer, potentially leading to vessel occlusion or damage.
Covidien plc today announced that it has notified customers of a voluntary recall to address an issue with certain lots of its Pipeline™ Embolization Device and Alligator™ Retrieval Device where the polytetrafluoroethylene (PTFE) coating applied to the delivery wire could delaminate and detach from the devices.
Ventilator may stop functioning, triggering the safety alarm and causing the patient to suddenly be required to breathe on his or her own.
Health risk of life-threatening infection to the blood stream or patency of device may not be maintained and clotting may occur.
August 19, 2013 - Mansfield, MA – Covidien today announced that it has initiated a voluntary recall of certain lots of Monoject prefill flush syringes. Reasons for Recall: This recall is being conducted due to the risk that a number of the syringes were filled with water but not subjected to the autoclave sterilization process.