“Could this be a problem with the label printing software?” – Brian Pate Company: Smiths Medical ASD Inc. Date of Enforcement Report 10/10/2018 Class III: PRODUCT First Breath Adult Nasal Cannula, REF 001283, Non-flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style Recall Number: Z-0071-2019 REASON “Manufactured” and “Use By” labels are transposed incorrectly suggesting the...Read More

This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. The pdf at the link provided contains a set of FDA reference documents and partial examples used in SoftwareCPR training courses on Validation of Production and Quality System Software and Part 11. This is just a partial set and...Read More