BD PYXIS MDBNK TWR MN CR-4HH-5FM-P RxNow, REF: 169-131 containing software version 3.9.1.9
Summary
The FDA issued a Class II for BD PYXIS MDBNK TWR MN CR-4HH-5FM-P RxNow, REF: 169-131 containing software versi 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-2487-2024
Action Date
2024-08-14
Status
Ongoing
Category
device
Product Description
BD PYXIS MDBNK TWR MN CR-4HH-5FM-P RxNow, REF: 169-131 containing software version 3.9.1.9
Lot/Code Info: UDI: 10885403512568/ Serial Number: 16139674 16124908 16063924 16084467 16221549 16139675 16220875 16237258 16284001 15940400 15940104 15941703 15941654 15943750 15943749 15500696 15654711 15654721 15631099 15631104 15775749 15383480 15383481 15383475 15383486 15383487 15366328 15606170 15575974 15575976 15490745 15422133 15853047 15902413 15598095 15550853 15437809 15437812 15518269 15518273 15518270 15872432 15872429 15662816 15504833 15504836 15503511 15430948 15430963 15639687 15639724 15639720 15639718 15328493 15442794 15442789 15761398 15761401 15937579 15786154 15684803
Quantity Affected: 61 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-2487-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29