Class 2 Device Recall Pall "TNA1" Total Nutrient Admixture Filter

• Date Initiated by Firm: June 15, 2011
• Date Posted: June 30, 2011
• Recall Status: Terminated on January 10, 2013
• Recall Number: Z-2715-2011
• Recall Event ID: 59174
• 510(K)Number: K905794
• Product Classification: Filter, infusion line - Product Code FPB
• Product: Pall Total Nutrient Admixture Filter, 1.2 micron filter This filter is a 1.2 micron low protein binding membrane indicated for the removal of inadvertent particulate debris and microorganisms (Candida Albicans) from total nutrient admixtures and undiluted intravenous fat emulsions. Product is designed for use with intravenous infusion pumps only.
• Code Information: Exp. date 2015-07: Lots 032711, 032811, 033611 and 033711 Exp. date 2016-01: Lots 105912 and 106012
• FEI Number: 2647898
• Recalling Firm/ Manufacturer: Pall Life Sciences Puerto Rico Llc; Pall Blvd 99 & 100; Rd 194, Km 0.4; Fajardo PR 00738
• For Additional Information Contact: 787-863-1124
• Manufacturer Reason for Recall: Incorrect filter media used (0.2 um filter used instead of the required 1.2 um) within the TNA1 filter used with total parenteral nutrition mixtures.
• FDA Determined Cause: Labeling mix-ups
• Action: Pall Life Sciences LLC, sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 15, 2011 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The letter instructed customers to maintain the product in quarantine. If distributed, the letter request that customers notify the user to discontinue use. Additionally, customers were asked to complete and return an attached Recall Response Form. The letter also included instructions on how to return the product. Please contact the Customer Service Department at 516-801-9923, if you have questions.
• Quantity in Commerce: 15,575 units
• Distribution: Worldwide Distribution--USA (nationwide) including the states of CA, CO, CT, IL, KS, LA, MA, MO, MS, NC, NY, OK, SD, TX, WA, and WY, and Puerto Rico and the countries of Colombia and Costa Rica.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.

• 510(K) Database: 510(K)s with Product Code = FPB