Duodenoscope Models TJF-160F and TJF-160VF by Olympus: Safety Communication - Reprocessing Instructions Validated
FDA reviewed updated reprocessing instructions and validation data; FDA recommends that facilities implement them as soon as possible. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - March 15, 2016 Category: American Health Source Type: alerts
Arrow International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits by Teleflex Incorporated : Class I Recall - Sheath Body may become Separated from Sheath Hub
If the separation occurs, patient may bleed from the sheath. If bleeding is not promptly addressed, significant blood loss/exsanguination, interruption/loss of intra-aortic balloon pump treatment may occur. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - March 11, 2016 Category: American Health Source Type: alerts
Amikacin Sulfate Injection USP, 1 gram/4mL (250 mg/mL) Vials by Teva: Recall - Glass Particulate Matter
Administration of a glass particulate may result in local irritation, swelling, and blockage or clotting in blood vessels, which may be life-threatening if a critical organ is affected. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - March 10, 2016 Category: American Health Source Type: alerts
Human and Animal Sterile Drug Products by I.V. Specialty: FDA Alert - Lack of Sterility Assurance
Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - March 9, 2016 Category: American Health Source Type: alerts
Fluconazole Injection, USP, (in 0.9 Percent Sodium Chloride) 200mg per 100ml: Recall - Elevated Impurity
Fluconazole Injection, USP, (in 0.9% Sodium Chloride) 200mg per 100ml: Recall - Elevated Impurity (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - March 5, 2016 Category: American Health Source Type: alerts
MitraClip Delivery System by Abbott: Safety Notice - Reinforcement of Proper Procedures to Operate and Deploy
Abbott requiring training of all MitraClip implanting physicians to ensure continued safe use of the device. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - February 29, 2016 Category: American Health Source Type: alerts
Neurosurgical Head Holders (Skull Clamps) : FDA Safety Communication - Device Slippage
Unintended patient movement during surgical procedures may result in injuries including skull fractures, facial injuries (bruises and cuts), deep cuts (lacerations), and blood clots (hematoma). Posted 02/25/2016 (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - February 25, 2016 Category: American Health Source Type: alerts
ED-3490TK Video Duodenoscope by Pentax: FDA Safety Communication - Pentax Validates Reprocessing Instructions
FDA reviewed updated reprocessing instructions and validation data; FDA recommends that facilities
implement them as soon as possible. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - February 19, 2016 Category: American Health Source Type: alerts
0.9 Percent Sodium Chloride Solution for Irrigation by Baxter: Recall - Presence of Particulate Matter
Use of Sodium Chloride Irrigation solution with foreign material contamination could result in inflammatory reaction, foreign body reaction, and infection which could be life-threatening. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - February 18, 2016 Category: American Health Source Type: alerts
Morphine Sulfate 0.5 mg/mL Preservative Free in 0.9 percent Sodium Chloride by Pharmakon Pharmaceuticals: Recall - Super-potent Product
Injecting a patient with super-potent morphine could result in serious consequences including respiratory depression, coma, and death. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - February 17, 2016 Category: American Health Source Type: alerts
Central Venous Catheters and Pressure Monitoring Sets and Trays by Cook Medical: Recall - Catheter Tip Fracture and/or Separation
Risk of stroke, kidney injury, or damage to the intestines or limbs. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - February 11, 2016 Category: American Health Source Type: alerts
Syrspend SF and Syrspend SF Grape Suspending Agents by Fagron: FDA Alert - Microbial Contamination with Yeast
If an immunocompromised patient or a child with an immature immune system ingests the contaminated product, there is a potential the patient will get an infection for which systemic antimicrobial therapy would be necessary. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - February 11, 2016 Category: American Health Source Type: alerts
Oxylog 2000 Plus, 3000, and 3000 Plus Emergency Transport Ventilators by Dräger Medical: Class I Recall - System Error May Lead to a Halt in Ventilation Therapy
If the device operator does not intervene, the patient may not receive enough oxygen and could suffer serious adverse health consequences, including injury or death. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - February 10, 2016 Category: American Health Source Type: alerts
Pink Bikini and Shorts on The Beach Dietary Supplements by Lucy's Weight Loss System: Recall - Undeclared Drug Ingredient
May contain sibutramine, phenolphthalein, and/or diclofenac. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - January 29, 2016 Category: American Health Source Type: alerts
Bentonite Me Baby – Bentonite Clay by Alikay Naturals: Consumer Warning - Risk of Lead Poisoning
Exposure to lead can cause serious damage to the central nervous system, the kidneys, and the immune system. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - January 28, 2016 Category: American Health Source Type: alerts
