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Physio-Control has announced a recall of specific lots of its Quik-Combo adult pacing/defibrillation/ECG electrodes and its Red-Pak preconnected system due to possible damage to the wire insulation during the manufacturing process. Read More
Innovative Sterilization Technologies has received an FDA warning letter for failing to establish and maintain procedures when dealing with contract manufacturers. Read More
The FDA is calling on healthcare facilities to immediately implement employee training for updated reprocessing instructions for two Olympus duodenoscope models. Read More
The third time is not always the charm, as radiology clinic MRI Imaging Specialist learned the hard way following three failed FDA inspections in nearly two years, a recent FDA warning letter shows. Read More
Cook Medical is recalling 360 specific lots of single lumen central venous catheters and pressure monitoring sets and trays due to catheter tip fracture and/or separation. Read More
Dealing with tense inspections can be challenging, but learning what to do in real-world scenarios can help firms prepare. Steve Niedelman, lead quality systems and compliance consultant at King & Spalding and former FDA deputy associate commissioner for regulatory operations, and Elaine Messa, president of the Medical Device Practice at NSF Health Sciences and former director of the Los Angeles District at the FDA, provide advice on the topic during the FDAnews’ Medical Device Quality Congress on March 16. Read More
Terumo Medical has earned a warning letter from the FDA due to procedural failures for controlling product conformity, as well as validating and verifying device design. Read More