Pall Total Nutrient Admixture Filter, 1.2 micron filter This filter is a 1.2 micron low protein binding membrane indicat
FDA device recall Z-2715-2011 · posted 2011-06-30 · Terminated
Recall details
- Recalling firm
- Pall Life Sciences Puerto Rico Llc
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- FPB
- Quantity affected
- 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.
- Date initiated
- 2011-06-15
- Date posted
- 2011-06-30
- Date terminated
- 2013-01-10
- Location
- Fajardo, PR
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PALL 3N1 FILTER (K905794) | Pall Biomedical Products Co. | 1991-06-13 |