All Entries in the "Medical Products" Category
OneTouch SureStep Test Strips (LifeScan): Recall
Test strips are being recalled because they may provide falsely low glucose results when the glucose level is higher than 400 mg/dL.
Abiomed AB5000 Circulatory Support System: Class I Recall
Device computer may shut down without an alarm, which can lead to serious injuries or death.
Baylis Medical Torflex Transseptal Guiding Sheath: Class I Recall
Sheath tip may break off and separate during heart procedures, causing a blockage that could lead to permanent injury and/or death.
Beckman Coulter UniCel DxC Synchron Clinical System – Ion Selective Electrode Flow Cell: Class I Recall
Incorrect sodium results may be caused by build-up of protein, bacteria, and sample tube additives in the ion selective electrode flow cell.
Counterfeit Polypropylene Surgical Mesh: Initial Communication
Various sizes of counterfeit flat sheets of polypropylene surgical mesh are being marketed in the United States labeled with the C. R. Bard/Davol brand name.
Teleflex Arrow IV Tubing Sets, Accessories, and Embolectomy Catheters: Recall
Product sterility cannot be guaranteed. Testing revealed pin holes in some of the pouches in which the products are packaged.
Ear Candles: Risk of Serious Injuries
FDA is notifying consumers and healthcare providers of its warning not to use ear candles - a hollow cone about 10 inches long made from a fabric tube soaked in beeswax, paraffin or a mixture of the two - because they can cause serious injuries, even when used according to the manufacturer’s directions. According to advertised claims, a burning [...]
Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport by Thomas Medical
Sheath tip may break off and separate while the sheath is inside a blood vessel, leading to serious injury or death.
Edwards Lifesciences Aquarius Hemodialysis System: Recall
Clinically significant fluid imbalance and potential for users to repeatedly override the fluid imbalance alarm.
Hettich Centrifuges with 2050 and 2076 Plastic Rotors: Recall
Plastic centrifuge rotor may crack, break apart and be forcefully ejected.
Infusion Set Needles [Manufactured by Nipro for Exelint]: Recall
Class I recall due to “coring” or dislodging of silicone cores or slivers from the ports into which they are inserted.
