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August MedSun Newsletter
Recalls and Safety Alerts:
Atar Extension Cables by Oscor: Recall
During the use of some affected devices, the cable was separating from the connector at the proximal end. The analysis of the returned devices revealed a change in the manufacturing sequence attributed to the connector and wire separation, causing a fracture of the conductor cable from extensive use...
Penumbra 3D Revascularization Device by Penumbra: Class I Recall
Risk of the delivery wire breaking or separating during use. Fractured pieces of the delivery wire could be left inside the patient’s brain bloodstream, and this or the attempts made to retrieve the fractured pieces, can make the stroke worse...
ED-530XT Duodenoscopes by Fujifilm: Safety Communication
On July 21, 2017, Fujifilm issued an Urgent Medical Device Correction and Removal notification informing customers of its voluntary recall of all ED-530XT duodenoscopes. This action includes replacement of the ED-530XT forceps elevator mechanism including the O-ring seal, replacement of the distal end cap, and new Operation Manuals. The FDA cleared the updated design and labeling for the ED-530XT on July 21, 2017...
LeadCare Testing Systems (with Blood Obtained from a Vein) by Magellan Diagnostics
Updated statement on the status of FDA’s investigation into inaccurate results from certain lead tests, including release of inspection report...
Novopen Echo Insulin Delivery Device by Novo Nordisk: Recall
Novo Nordisk is initiating a recall of insulin cartridge holders used in a small number of NovoPen Echo batches because they may crack or break if exposed to certain chemicals, like certain cleaning agents. Using a device with a cracked/broken cartridge holder may result in the device delivering a reduced dose of insulin which could potentially lead to high blood sugar...
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