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U.S. Department of Health and Human Services

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

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 Class 2 Recall
Pall "TNA1" Total Nutrient Admixture Filter
see related information
Date Posted June 30, 2011
Recall Status1 Terminated on January 10, 2013
Recall Number Z-2715-2011
Recall Event ID 59174
Premarket Notification
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
Recalling Firm/
Manufacturer
Pall Life Sciences Puerto Rico Llc
Pall Blvd 99 & 100
Rd 194, Km 0.4
Fajardo, Puerto Rico 00738
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 2
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FPB and Original Applicant = PALL BIOMEDICAL PRODUCTS CO.
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