Re: Lot number documentation

[Jlacyrn2]

Interestingly 2006 INS Standards only make a reference to recording labeling information`in Standard 15  Product Evaluation, Integrity, and Defect Reporting - Practice Criteria - L - "Serial and lot numbers used in product identification, tracing, and product recall should be retained."  This is in reference to product defect reporting. Without documentation can it be retrieved?   The FDA User Facility Medical Device Reporting requirements that exist in law 21CFR803.30 state that "Product model, catalog, serial and lot number" are required elements of reporting.   SIR Standards (Omary, R. A., M. A. Bettmann, et al. (2003). "Quality improvement guidelines for the reporting and archiving of interventional radiology procedures." J Vasc Interv Radiol 14(9 Pt 2): S293-5) state,  "For inserted medical devices, appropriate identifying iformation, such as the product name, vendor, and lot numbers, must be recorded."       Jim Lacy, RN, BSN, CRNI Contact: [EMAIL PROTECTED]  DO NOT REPLY DIRECTLY TO THE SENDER E-MAIL ADDRESS