CareFusion 303, Inc. recalls BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite MX is a modular infusion pump and monitoring system for the…
Due to User Manual/Direction for Use incorrectly instructing user to leave the safety clamp in the open position when reloading an infusion set. This issue potentially could result in an accidental over infusion if the…
Read the official notice →- Date
- 2025-03-05
- Country
- United States
- Brand
- CareFusion
- Product
- BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite MX is a modular infusion pump and monitoring system for the…
- Classification
- Class II
- Units
- U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More CareFusion recalls
- 2025-03-26
USCareFusion 303, Inc. recalls BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedStation ES Tower, REF: 352, CII Safe ES, REF: 1116-00, CII Safe ES…
Sync timeout may occur between the server and automated dispensing device, due to a server software error which may occur if syncing a large amount of data that takes excessive time, which may cause the dispensing…
FDA · DeviceCareFusion 303, Inc.Worldwide - US Nationwide distribution including in the states of KY, OH, NY,…Official notice →- 2025-03-19
- US
CareFusion 303, Inc. recalls BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software
Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).
FDA · DeviceCareFusion 303, Inc.US: AZ, CA, DC, FL, GA, IL, IN, MI, MO, NC, NJ, NY, OH, OR, PA, SC, TX, UT,…Official notice → - US
CareFusion 213, LLC recalls BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin…
Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
- 2025-03-05
- US
CareFusion 303, Inc. recalls 138913-01 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 169-114 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 138911-01 BD PYXIS MEDBANK MINI CR-4HH-P 169-115…
Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.
FDA · DeviceCareFusion 303, Inc.US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO,…Official notice → - US
CareFusion 303, Inc. recalls BD Pyxis MedFlex 2.0 REF 1139-00 Bio-ID Spare Parts REF 353200-01 The BD Pyxis" MedFlex is an Automated Dispensing Cabinet (ADC) intended…
Due to fingerprint scanner failing resulting in the scanner heating up.
FDA · DeviceCareFusion 303, Inc.Worldwide - U.S. Nationwide distribution including in the states of AL, AZ,…Official notice → - US
CareFusion 303, Inc. recalls BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass, REF: 139088-01 and associated BD Pyxis user/software/safety…
Automated dispensing device labeling is being updated to strengthen labeling around manual access to medications to address the risk of potential delays in retrieving contents/ accessing medications that may result…
FDA · DeviceCareFusion 303, Inc.US Nationwide distribution including in the states of AZ, FL, NJ, KY, GA, CA,…Official notice →
Other drugs & medical recalls in the United States
- 2025-03-05
- US
Scientia Vascular, Inc. recalls Plato 17 Microcatheter REF PL17-160-090 To assist in delivery of therapeutic devices and embolization materials and infusion of…
Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this could potential create a breach in the sterile barrier.
FDA · DeviceScientia Vascular, Inc.U.S. Nationwide distribution in the state of DE.Official notice → - US
BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD. recalls DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.
Beckman Coulter has identified an issue which prevents the DxC 500 AU instrument from providing the correct onboard stability (Open Expiration) dates for assays that were loaded prior to a software upgrade (e.g. 1.3 to…
FDA · DeviceBECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.US: MA, CA, SC, LA, OK, GA, AL, TX, OR, ID, CO, MN, NY, MS, PA, WA, IL, MI,…Official notice → - US
Physio-Control, Inc. recalls LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest.
Incorrect keypad was incorrectly installed onto a defibrillator/monitor.
- US
CareFusion 303, Inc. recalls 138913-01 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 169-114 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 138911-01 BD PYXIS MEDBANK MINI CR-4HH-P 169-115…
Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.
FDA · DeviceCareFusion 303, Inc.US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO,…Official notice → - US
Tyber Medical recalls A.L.P.S. mvX-MEDIAL TIBIA PLATE 12H LT-Medial Tibia Plate, 12-Hole, Left Intended forFixation of fractures of the distal tibia…
Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of…
- US
INTELERAD MEDICAL SYSTEMS INCORPORATED recalls IntelePACS (Image Fusion Module) - InteleViewer
A software application that receives digital images and data from various sources has a bug in specific software versions that will calculate the Standard Uptake Value (SUV) incorrectly for PET/CT studies acquired on…
FDA · DeviceINTELERAD MEDICAL SYSTEMS INCORPORATEDWorldwide - US Nationwide distribution in the states of AZ, NC, MI, FL, NH,…Official notice →