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Medicine Recalls

The HeartMate 3 Left Ventricular Assist System may allow blood to leak out or air to enter the system during implant of the LVAD device. 5/15/2024

The FDA issues alert about risk of false results with Cue Health's COVID-19 Tests due to modifications made without FDA authorization that have a strong likelihood to impact performance. 5/13/2024

Philips Respironics is recalling their Trilogy Evo ventilators due to a software-related possible power malfunction, leading to a sudden loss of ventilation. 5/13/2024

MEGADYNET is initiating a voluntary recall of all MEGADYNET MEGA SOFTT Pediatric Patient Return Electrodes. The product is being removed because Megadyne has received reports of patient burn injuries in procedures where the Mega Soft Patient Return Electrodes were used. A root cause investigation... 5/10/2024

Route 92 Medical is recalling certain products that include Tenzing 7 Delivery Catheters due to instances of the catheter tip separating near the marker band. 5/10/2024

Health care providers and facilities should begin to transition away from these devices and seek alternatives. 5/8/2024

Tandem Diabetes Care, Inc. recalls t:connect mobile app (v2.7) for t:slim X2 insulin pump due to software issue that may cause app to crash and deplete pump battery 5/8/2024

BioMerieux is recalling their VITEK 2 AST cards, used for testing bacterial sensitivity to antibiotics, due to excessive Ceftriaxone in two wells. 4/30/2024

SonarMed Airway acoustic sensors recalled due to a restricted inner diameter resulting in difficulty passing a suction catheter through the sensor. 4/29/2024

SonarMed Airway monitors recalled for a software issue where it fails to detect partial obstructions in 2.5mm sensors and within 3mm of sensor tip. 4/29/2024

Elekta recalls Disposable Biopsy Needles (911933) from batch 837838839 due to potential microscopic stainless steel debris inside. 4/26/2024

These choking rescue protocols include abdominal thrusts (also called the "Heimlich" maneuver) for children and adults but not anti-choking devices. 4/26/2024

The Perseus A500 that provides anesthesia and/or ventilation during surgical or diagnostic procedures may unexpectedly shutdown while using battery power. 4/25/2024

Fresenius Stay-Safe Catheter Extension Sets and Stay-Safe/Luer Lock Adapter may expose patients who weigh less than 40 kg to higher than allowable levels of NDL-PCBA. 4/25/2024

Nimbus and Nimbus II infusion pumps may experience one or more issues that can cause severe patient injury and death. 4/25/2024

The Tablo Hemodialysis System may expose patients to higher than allowable levels of NDL-PCBAs. 4/25/2024

DeRoyal is recalling Surgical Tracecarts with Nurse Assist 16FR Silver Urine Meter Foley due to sterility concerns. Other items in the tracecart are unaffected. 4/24/2024

Obsidio Embolic may cause bowel ischemia if used with the aliquot technique to address lower GI bleeding. 4/17/2024

Fresenius Kabi is recalling Ivenix Infusion System (IIS), LVP, due to several software issues that could cause serious harm or death to patients. 4/17/2024

HeartMate II and HeartMate 3 devices are being recalled because a buildup of biological material is obstructing the device, making it more difficult for the heart to pump blood. 4/15/2024

Medos International Sarl is recalling Cerenovus CEREBASE DA Guide Sheath due to fractures in the distal catheter shaft where parts are joined. 4/4/2024

Smiths Medical ParaPAC Plus ventilators are used in transport and emergencies. A malfunction keeps the ventilator from providing necessary breathing support. 4/4/2024

ARROW QuickFlash Catheterization Kits are being recalled after reports of increased resistance with the guide wire and chamber during use. 4/3/2024

East Windsor, New Jersey, Eugia US LLC (f/k/a AuroMedics Pharma LLC) has initiated a voluntary recall of lot number 3MC23011 of Methocarbamol Injection, USP 1000 mg/10 mL (100mg/mL) (Single Dose Vial) - 10mL Vial to the consumer level due to a customer product complaint for the presence of white... 3/28/2024

Amneal Pharmaceuticals, LLC. Bridgewater, New Jersey (Amneal), is voluntarily recalling 4 lots (see table below) of Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL packaged in 80 mL, 150 mL, or 300 mL pack sizes, to the Consumer Level. Some bottles may have been overfilled which can... 3/27/2024

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