Baxter Healthcare Corporation recalls Baxter Flo-Thru Intraluminal Shunt, Product Codes: a) Product Code FT12100, 1.00 GLOBAL; b) Product Code FT12125, 1.25 GLOBAL; c)…
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or…
Read the official notice →- Date
- 2024-01-17
- Country
- United States
- Brand
- Baxter Healthcare
- Product
- Baxter Flo-Thru Intraluminal Shunt, Product Codes: a) Product Code FT12100, 1.00 GLOBAL; b) Product Code FT12125, 1.25 GLOBAL; c) Product…
- Classification
- Class II
- Units
- US Nationwide distribution.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Baxter Healthcare recalls
- 2024-02-28
USBaxter Healthcare Corporation recalls Baxter Exactamix Pro 1200, REF EXM12DY
An error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" feature which may lead to over-delivery of an ingredient. This issue can result in redundant ingredient delivery of the…
FDA · DeviceBaxter Healthcare CorporationUS: AL, AZ, CA, FL, GA, IA, KY, MD, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OR,…Official notice →- US
Baxter Healthcare Corporation recalls Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL), For Intravenous Infusion Only, 250 mL vial, Rx Only,…
Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the primary bag label correctly identified the product strength as 8 mg /…
- 2024-01-17
- US
Baxter Healthcare Corporation recalls XScribe CP Cardiac Stress Testing System, version 6, with below product names and codes: a) X-SCRIBE CPI KIT WIRELESS USB 608 MHz,…
Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.
FDA · DeviceBaxter Healthcare CorporationUnited States (including Puerto Rico), Canada, Australia, Bangladesh, Brunei,…Official notice → - 2023-12-20
- US
Baxter Healthcare Corporation recalls Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479
There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test occurring on the Amia devices.
FDA · DeviceBaxter Healthcare CorporationWorldwide distribution - US Nationwide and the country of Canada.Official notice → - 2023-12-13
- US
- 2023-11-15
- US
Baxter Healthcare Corporation recalls Novum IQ Syringe infusion system, Product Code 40800BAXUS
Baxter is issuing an Urgent Medical Device Correction for the Novum IQ Syringe Pump. Baxter identified that after multiple downstream occlusion alarms, the pump may display an Infusion Complete alarm even though…
FDA · DeviceBaxter Healthcare CorporationUS Nationwide Distribution to states of: AR, AZ, CA, FL, GA, HI, IA, IN, KS,…Official notice →
Other drugs & medical recalls in the United States
- 2024-01-17
- US
Cordis US Corp recalls MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites.
Cordis became aware that the label for the carton box containing 10 units is incorrect for some boxes of two lots of MynxGrip. The carton box from lot F2322902 (Item MX5021, MynxGrip 5F) as labeled as lot F2322903…
- US
Boston Scientific Corporation recalls Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 2892 Programmer Application…
The software application on the Programmer/Recorder/Monitor (PRM) for Implantable Pulse Generators will display certain diagnostic dates incorrectly, with a year in the 1990s.
FDA · DeviceBoston Scientific CorporationDistribution was nationwide, including Guam, Puerto Rico, and the U.S. Virgin…Official notice → - US
Townsend Design recalls SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) non locking, REF #s: 17VKCUS and 17VKCUSX
Due to potential air pockets between layers of material, their is the potential for complete struct breakage of knee-ankle-foot orthosis.
FDA · DeviceTownsend DesignUS: AL AR AZ CA CO CT DC DE FL GA IA ID IL IN KENT KS KY LA MA MD ME MI MN MO…Official notice → - US
Abiomed, Inc. recalls Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045, 1000080)-Introducer(s) are intended for…
Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of…
FDA · DeviceAbiomed, Inc.Nationwide Foreign: Country AT AU BE BR CA CA CH CZ DE DK ES FR FR HK IN IT MX…Official notice → - US
Olympus Corporation of the Americas recalls OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S190-5 Used with a video system center, light…
Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. The steps are required for the proper reprocessing of these videoscopes
- US
Bard Peripheral Vascular Inc recalls Bard Mission Disposable Core Biopsy Instrument Kit (REF/Name): 1410MSK/ Mission Kit 14G x 10CM; 1416MSK/ Mission Kit 14G x 16CM;…
The internal diameter of the coaxial cannula may be smaller or larger than the external diameter of the biopsy needle, and the length of the cannula may exceed the stated length on the label. As a result, the biopsy…
FDA · DeviceBard Peripheral Vascular IncWorldwide - US Nationwide distribution including in the states of PR, IL, MA,…Official notice →