News

Special Alerts & Recalls

Chlorhexidine Gluconate: Drug Safety Communication – Rare but Serious Allergic Reactions - February 2017 FDA is warning that rare but serious allergic reactions have been reported with the widely used skin antiseptic products containing chlorhexidine gluconate. Although rare, the number of reports of serious allergic reactions to these products has increased over the last several years.

Recall for Over 205,000 Fresenius 2008 Dialysis Machines due to UF Rate Errors - January 2017 When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine.

Tego Connector Recall - January 2017 The Tego Needle Free Access Device is intended for use as an accessory to a vascular access device (catheter) used in Hemodialysis or as an accessory to an Intravascular Administration Set for the administration or withdrawal of fluids to a patient through a cannula or needle placed in the vein or artery. The Tego is a needle-free capping device which closes the end of the catheter. The Tego will permit access to the catheter without the use of needles and therefore passively aid in the reduction of needle stick injuries.

Skintact DF29N Multi-function Defibrillation Electrodes by Leonhard Lang: Class I Recall - Connector Compatibility Issue - October 2016 The Leonhard Lang defibrillation electrode is being recalled due to a connector compatibility issue with the Welch Allyn AED model 10. The user may not be able to connect the electrodes to the defibrillator when a shock is needed. This may result in a delay in delivering the electrical therapy needed to revive a patient in cardiac arrest, resulting in injur or death.

VASCU-GUARD Peripheral Vascular Patch by Baxter International: Letter to Health Care Providers - Potential Risk of Severe Bleeding and Hematomas - September 2016 The FDA has recently received multiple adverse event reports associated with Baxter International Inc.’s Vascu-Guard Peripheral Vascular Patch (also referred to as the Vascu-Guard patch) during carotid endarterectomy (CEA). These reports from 2016 include intraoperative or postoperative bleeding and hematomas, some of which required additional clinical intervention, and three patient deaths potentially related to this issue that occurred shortly after CEA surgery.

Eyesaline Eyewash by Honeywell: Recall - Microbial Contamination - August 2016 Honeywell is voluntarily recalling one production lot of 32-ounce bottles of Eyesaline Eyewash solution, which is used for emergency eye rinsing after an injury. Although no injuries have been reported and no contamination was found in batch testing, there is a risk of product contamination with Klebsiella pneumoniae.

PharmaTech LLC Issues Voluntary Nationwide Recall Due to Potential Risk of Product Contamination - August 2016  PharmaTech, LLC of Davie, FL, is voluntarily recalling all liquid products from October 20, 2015 through July 15, 2016 as a precautionary measure due to a potential risk of product contamination with Burkholderia cepacia.

Oral Liquid Docusate Sodium by PharmaTech: Recall – Contaminated with B. Cepacia   7/18/2016-The FDA is alerting healthcare professionals that PharmaTech LLC, Davie, Florida, is voluntarily recalling all non-expired lots of Diocto Liquid, a docusate sodium solution distributed by Rugby Laboratories, Livonia, Michigan. The agency confirmed the product has been contaminated with Burkholderia cepacia, a bacteria linked to an outbreak in five states.

Baxter Issues Voluntary National Recall of One Lot of 0.9% Sodium Chloride Solution for Irrigation Due to Presence of Particulate Matter  - updated 2/22/16- Baxter International Inc. of Deerfield, Illinois, is voluntarily recalling one lot of 0.9% Sodium Chloride Irrigation, USP, 500 mL Plastic Pour Bottle solution to the hospital/user level. This product is being recalled due to a customer complaint prior to use for the presence of particulate matter, identified as an insect.