BD Pyxis MedStation Auxiliary 4000 REF: 306. Intended to securely store and dispense medications to a qualified and aut
Summary
The FDA issued a Class II for BD Pyxis MedStation Auxiliary 4000 REF: 306. Intended to securely store and dis by CareFusion 303, Inc.. Reason: Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in dela.
Details
Source
Device Recall
External ID
Z-1124-2025
Action Date
2025-02-19
Status
Ongoing
Category
device
Product Description
BD Pyxis MedStation Auxiliary 4000 REF: 306. Intended to securely store and dispense medications to a qualified and authorized healthcare provider.
Lot/Code Info: UDI: 10885403512636/ Serial Numbers: 16187325, 16187326, 16187327, 16173446
Reason for Recall
Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in accessing medications.
Distribution
US: Nationwide OUS:JP IT IN DE GB KR NL TW ES BE AU BH CA BR NZ FR AR QA MX CL TR SA MY CH IL IE TH SG KW MA FI AE EG BS BM GR MC PL LB MO IQ TN NO PH CN HK CO JO OM
Type: Voluntary: Firm initiated
Recall Initiated: 2024-02-23
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 142 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-1124-2025" 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