BKIT BD Pyxis QFill Replenishment Station, REF: 155197-01, medication cabinet system
Summary
The FDA issued a Class II for BKIT BD Pyxis QFill Replenishment Station, REF: 155197-01, medication cabinet sy by CareFusion 303, Inc.. Reason: Due to software issue, there is a potential when a restock label is printed for a medication stored in a non-CUBIE location, that the incorrect bin fo.
Details
Source
Device Recall
External ID
Z-2948-2024
Action Date
2024-09-11
Status
Ongoing
Category
device
Product Description
BKIT BD Pyxis QFill Replenishment Station, REF: 155197-01, medication cabinet system
Lot/Code Info: serial numbers: 16056243 16068264 16082950 16142772 16192674 16208218 16208219 16284106 16346254 16388826 16388833 16623139 / UDI: None
Reason for Recall
Due to software issue, there is a potential when a restock label is printed for a medication stored in a non-CUBIE location, that the incorrect bin for the medication is printed on the label.
Distribution
US Nationwide distribution in the states of CA, FL, KS, MN, NJ, NY, PA.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-07-09
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 363 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-2948-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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