Z-2715-2011

Pall Total Nutrient Admixture Filter, 1.2 micron filter This filter is a 1.2 micron low protein binding...

Name: Z-2715-2011 Pall Total Nutrient Admixture Filter, 1.2 micron filter This filter is a 1.2 micron low protein binding...
Creator: Pall Life Sciences Puerto Rico Llc
Published: 2011-06-15
License: https://open.fda.gov/license/

Pall Life Sciences Puerto Rico LLC / initiated 2011-06-15 / Terminated / root cause: labeling and UDI

FDA source

Pall Life Sciences Puerto Rico Llc began a recall of 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... on 2011-06-15. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2715-2011
Status: Terminated
Initiated: 2011-06-15
Posted: 2011-06-30
Terminated: 2013-01-10
Recalling firm: Pall Life Sciences Puerto Rico LLC
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.
Product code: FPB Filter, Infusion Line
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.
Root cause tag: labeling and UDI
FDA root 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.
Product codes and lots: Exp. date 2015-07: Lots 032711, 032811, 033611 and 033711 Exp. date 2016-01: Lots 105912 and 106012

Product code FPB

K905794Class IIPall 3N1 FilterPall Biomedical Products Co. / cleared 1991-06-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)