Company: Cleveland Medical Devices Inc.Date: 9/17/01 Product: Wireless medical telemetry monitoring systems No documented corrective and preventative action for software bugs found during retrospective validation. Validation testing revealed several responses that were unexpected and may potentially adversely effect the performance of the Model 15 The above stated inspection revealed that your devices are adulterated within...Read More

Company: B. Braun Medical Inc.Date: 9/17/01 Product: Disposable IV sets Failure to validate computer software used to (1) control the Eto sterilization process, for example, _____ cycles, and (2) control the _____ _____) employed in the manufacture of disposable IV sets, to ensure the software will perform for its intended use. 21 CFR 820.70(i). FDA...Read More