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Analysis of customer data, (for ABL 8X7 customers) has shown that the reference membranes are out of analytical specifications when replaced as specified in the device labeling. These errors in analytical specifications could lead to inadequate or clinical interventions (therapy) or misleading interpretation of patient status in clinical settings.
This recall involves Zebco Advanced Youth Fishing Rod & Reel combo sets. The reels are painted orange and have the words "Zebco" and "ZAVS 10" on the reel handle. Only spinning reels are involved in this recall.
Device operation interrupted: A software bug causes Phaco to stop when vacuum goes above 300 mmHg while in Multi Burst mode. Use of this product at the parameters specified above could lead to a delay in surgery that might present a health risk.