FDAClass IIAugust 14, 2024

BD Pyxis Medbank TWR MN Cr-8hh-3fm-p recall: Software Issue

BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P, REF: 169-99 containing software version 3.9.1.9

Why was BD Pyxis Medbank TWR MN Cr-8hh-3fm-p recalled?

Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI: 10885403512568/ Serial Number: 16210468 16274000 16232272 16209954 16209953 16097230 16184767 16101319 16095341 16112043 15815836 15631124 15632972 15937573 16073534 16173241

Product
BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P, REF: 169-99 containing software version 3.9.1.9
Recalling firm
CareFusion 303, Inc.
Quantity
16 units
Distribution
US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV.
Recall date
August 14, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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