Recall Z-2715-2011 ยท FPB Filter, Infusion Line
Pall Life Sciences Puerto Rico Llc
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.
| Date | Jun 30, 2011 (initiated Jun 15, 2011) |
| Status | Terminated |
| Reason | 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 | 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K905794 | PALL 3N1 FILTER Pall Biomedical Products Co., Jun 13, 1991 |