Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Pall "TNA1" Total Nutrient Admixture Filter see related information
Date Initiated by Firm June 15, 2011
Date Posted June 30, 2011
Recall Status1 Terminated 3 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
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 2		 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 and Original Applicant = PALL BIOMEDICAL PRODUCTS CO.
-
-