The upswing of Class I recalls in fiscal 2004 is not necessarily a cause for alarm, CDRH Office of Compliance Director Tim Ulatowski suggested at the Indiana Medical Device Manufacturers Council annual meeting in Indianapolis Oct. 26

The upswing of Class I recalls in fiscal 2004 is not necessarily a cause for alarm, CDRH Office of Compliance Director Tim Ulatowski suggested at the Indiana Medical Device Manufacturers Council annual meeting in Indianapolis Oct. 26

Medibo initiates Class I recall of 64 units of the battery-powered patient lifts Aug. 4 due to mechanical problems. Some hanger bars detached because of missing spring washers, causing patients to fall, the agency says. Further Minerva problems cited include loose foot-pedal assembly bolts and faulty actuator brackets on the mast assembly, resulting in lift instability. The recall continues a rising trend in Class I recalls (1"The Gray Sheet" July 19, 2004, p. 16). The Minerva patient lift is technically identical to Arjo's Minstrel, recalled earlier this year...