BD PYXIS MEDBANK MINI CR-2HH-1FH-P, REF: 169-114 containing software version 3.9.1.9
Summary
The FDA issued a Class II for BD PYXIS MEDBANK MINI CR-2HH-1FH-P, REF: 169-114 containing software version 3.9 by CareFusion 303, Inc.. Reason: Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorre.
Details
Source
Device Recall
External ID
Z-2485-2024
Action Date
2024-08-14
Status
Ongoing
Category
device
Product Description
BD PYXIS MEDBANK MINI CR-2HH-1FH-P, REF: 169-114 containing software version 3.9.1.9
Lot/Code Info: UDI: 10885403512544/ Serial Number: 16132658 16168374 16097985 16191227 16221557 16203700 16198296 16034793 16207656 16221556 16225067 16138830 16039764 15950395 16042993 15967360 15378118 16155519 16090203 16216083 16112389 16035948 16256357 15940923 15940150 15961968 15950397 15950399 16055233 15442769 16243553 15832653 16085678 16044038 16044042 16044015 16044016 16044019 16044022 16044021 16044034 16044026 16044032 16044027 16044029 16044031 16044046 15499064 15948854 15490767 15631138 15378120 15378121 15409640 15910842 15353919 15547821 15049511 15618006 15371604 15872431 15657867 15364475 15506571 15326870 15906089 15906091 15906093 15328486 15442778 15506570 16061648 16061659 16061660 16034792 15353916 16161290 16271157 16271158 16271159 16042049 16042051 16042052 16042053
Quantity Affected: 84 units
Reason for Recall
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-06-24
Company
San Diego, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 158 device recalls issued in the same week, part of 413 device-related FDA actions this month.
CareFusion 303, Inc. has 105 FDA actions in our database, including 103 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (CareFusion 303, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does CareFusion 303, Inc. have FDA actions?
CareFusion 303, Inc. has 105 FDA actions in our database, including 103 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2485-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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