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.
FDA Recall Z-2715-2011 · Posted 2011-06-30
Recalling FirmPall Life Sciences Puerto Rico Llc
Recall StatusTerminated
Product CodeFPB
Date Initiated2011-06-15
Date Terminated2013-01-10
Product Quantity15,575 units
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.
Firm 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.
Root Cause
Labeling mix-ups
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.