Class I Medical Device Recall: Arrow Ultra 8 Intra-Aortic Balloon Catheters (IABS) 8 FR 30CC and 40CC Universal and Arrow Intra-Aortic Balloon (IAB) Catheter with a Fiber Optic Sensor and Measurement System

Recall Class: Class I Date Recall Initiated: October 11, 2010 Products:Arrow IAB (Intra Aortic Balloon), Ultra 8 Fr, 30cc Arrow IAB (Intra Aortic Balloon), Ultra 8 Fr, 40cc Arrow Intra-Aortic Balloon (IAB) Catheter with a Fiber Optic Sensor and a Measurement System, 30cc Arrow Intra-Aortic Balloon (IAB) Catheter with a Fiber Optic Sensor and a [...]

Sodium Bicarbonate Injection, USP, 7.5% and 8.4%, 50 mL Single Dose Vials

[Posted 12/29/2010]   AUDIENCE: Hospital Risk Managers, Pharmacy, Emergency Medicine ISSUE: American Regent and FDA notified healthcare professionals of the nationwide recall of  specific lots of Sodium Bicarbonate Injection, USP, 7.5% and 8.4%, 50 mL Single Dose Vials because some vials of these lots contain particulates. Potential adverse events after intravenous administration include damage to [...]

Class I Medical Device Recall: ev3 NanoCross .014 OTW PTA Dilatation Catheter

Recall Class: Class I Date Recall Initiated: November 10, 2010 Product: NanoCross .014″ PTA Balloon Catheter Manufacturing From: May 27, 2010 – October 18, 2010 Distribution From: June 8, 2010 – November 4, 2010 The following model and lot numbers affected can be found using the following List Number Configurations: Use: The NanoCross 0.014” OTW [...]

FDA Drug Safety Communication: Ongoing safety review of Recombinant Human Growth Hormone (somatropin) and possible increased risk of death

Safety Announcement Additional Information for Patients Additional Information for Healthcare Professionals Data Summary   Safety Announcement [12-22-2010] The U.S. Food and Drug Administration (FDA) is informing the public that results from a study conducted in France—the Santé Adulte GH Enfant (SAGhE) study—found that persons with certain kinds of short stature (idiopathic growth hormone deficiency and [...]

Questions and Answers About the Abbott Glucose Test Strip Recall

How can I report problems with glucose test strips to the FDA? What products are affected? Abbott Diabetes Care is recalling 359 different lots of glucose test strips. The strips include the following brands: Medisense Optium Optium OptiumEZ Prescision Xtra ReliOn Ultima Precision Xceed Pro These strips are used with the following blood glucose monitoring [...]

Recombinant Human Growth Hormone (somatropin): Ongoing Safety Review

[Posted 12/22/2010] AUDIENCE: Pediatrics, Endocrinology ISSUE: FDA is informing the public that results from a study conducted in France — the Santé Adulte GH Enfant (SAGhE) study — found that persons with certain kinds of short stature (idiopathic growth hormone deficiency and idiopathic or gestational short stature) treated with recombinant human growth hormone during childhood [...]

Post-Approval Study Database Updated with new data fields describing the study Protocol

Post-Approval Studies In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH). The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval [...]

Class I Medical Device Recall: Fresenius Kabi LLC, Red Blood Cell (RBC) Exchange Sets used on AS104 Blood Cell Separation Devices

Recall Class: Class I Date Recall Initiated: October 18, 2010 Product(s): Red Blood Cell (RBC) Set (catalog number 9007601), lot numbers WKT252, YLT061, ZCT011, and ZGT052, manufactured from October 1, 2007 to July 30, 2010. 255 units are subject to this recall. The Company issued a Field Safety Corrective Action letter dated October 18, 2010 [...]

FDA Drug Safety Communication: Abnormal heart rhythms associated with use of Anzemet (dolasetron mesylate)

    Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary   Safety Announcement [12-17-2010] The U.S. Food and Drug Administration (FDA) is informing patients and healthcare professionals that the injection form of Anzemet (dolasetron mesylate) should no longer be used to prevent nausea and vomiting associated with cancer chemotherapy (CINV) in pediatric and adult [...]

FDA Safety Notification: Risk of Eye and Skin Injuries from High-powered, Hand-held Lasers Used for Pointing or Entertainment

Date Issued: Dec. 16, 2010 Audience: Consumers Product: Hand-held laser pointers that emit 5 milliwatts (mW) output power or higher. Purpose: The Food and Drug Administration (FDA) is alerting consumers about the risk of eye and skin injuries from high-powered laser pointers. Summary of Problem and Scope: The Food and Drug Administration (FDA) is alerting [...]