Hudson RCI Pediatric Anesthesia Breathing Circuits by Teleflex Medical: Class I Recall - Circuit Ends May Crack or Break
Defect could cause serious health risks, including delayed patient treatment, breathing difficulties, or death if not replaced immediately. (Source: FDA MedWatch)
Source: FDA MedWatch - October 7, 2014 Category: American Health Source Type: news
Ketorolac Tromethamine Injection, USP, 30mg/ml by Sagent Pharmaceuticals: Recall - Incorrect Labeling
The labeled expiration date is longer than the known stability of the product. (Source: FDA MedWatch)
Source: FDA MedWatch - October 6, 2014 Category: American Health Source Type: news
Bo Ying Compound by Eu Yan Sang (Hong Kong) Ltd: FDA/CDER Statement - 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)
Source: FDA MedWatch - September 27, 2014 Category: American Health Source Type: news
Xolair (omalizumab): Drug Safety Communication - Slightly Elevated Risk of Cardiovascular and Cerebrovascular Serious Adverse Events
FDA approves label changes after review of a five year safety study. (Source: FDA MedWatch)
Source: FDA MedWatch - September 26, 2014 Category: American Health Source Type: news
Potassium Chloride Injection (Baxter): Recall - Shipping Carton Mislabeling
Potential risk of medication error or delay in therapy for patients that require high concentration potassium chloride. (Source: FDA MedWatch)
Source: FDA MedWatch - September 17, 2014 Category: American Health Source Type: news
Heparin Sodium, 1,000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), In 0.9 percent Sodium Chloride Injection, 500 mL by Hospira: Recall - Particulate Matter
Risk of injected particulate material which may result in local inflammation, phlebitis, and/or low-level allergic response. (Source: FDA MedWatch)
Source: FDA MedWatch - September 12, 2014 Category: American Health Source Type: news
Pharmacy Creations Certain Products: Recall – Potential Non-Sterility
Compromised sterility of a product may lead to risk for infection (Source: FDA MedWatch)
Source: FDA MedWatch - September 6, 2014 Category: American Health Source Type: news
Martin Avenue Pharmacy, Inc. Compounded Sterile Preparations: Recall - Lack of Assurance of Sterility
Compromised sterility of a compounded preparation may lead to risk for infection. (Source: FDA MedWatch)
Source: FDA MedWatch - September 2, 2014 Category: American Health Source Type: news
Dermatend Original and Dermatend Ultra: Recall - Safety Concerns
Using these Dermatend products instead of seeking medical attention could result in delayed diagnosis of conditions such as cancer. (Source: FDA MedWatch)
Source: FDA MedWatch - September 2, 2014 Category: American Health Source Type: news
DePuy Synthes Craniomaxillofacial Distraction System: Class I Recall - May Reverse Directions After Surgery
Infants at highest risk for injury. Sudden obstruction of trachea could lead to respiratory arrest/death. In all patient populations, failure may result in need for surgical intervention to replace failed device. (Source: FDA MedWatch)
Source: FDA MedWatch - August 28, 2014 Category: American Health Source Type: news
Sterile Convenience Surgical Packs by Customed, Inc.: Recall - Potential Loss of Sterility
Potential adhesion defect which may lead to infection. (Source: FDA MedWatch)
Source: FDA MedWatch - August 26, 2014 Category: American Health Source Type: news
Children’s Medical Ventures Gel-E Donut and Squishon 2: Class 1 Recall - Possibility of Mold
Cladosporium and Penicillium Fungi which may cause difficulty in breathing, allergic reactions and serious health consequences, including death. (Source: FDA MedWatch)
Source: FDA MedWatch - August 22, 2014 Category: American Health Source Type: news
CloverSnare 4-Loop Vascular Retrieval Snare by Cook Medical: Recall - Risk of Loop to Separate From Shaft
Use of affected product may result in loss of device function, potential for embolization of snare fragments, and the potential need for intervention to retrieve the separated snare. (Source: FDA MedWatch)
Source: FDA MedWatch - August 20, 2014 Category: American Health Source Type: news
Diamondback 360 Peripheral Orbital Atherectomy System by Cardiovascular Systems: Class I Recall - Sheath May Fracture During Use
Fragments of the sheath could possibly block blood vessels. (Source: FDA MedWatch)
Source: FDA MedWatch - August 19, 2014 Category: American Health Source Type: news
Dianeal Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 2.5 Percent Dextrose 5000mL (Ambu-Flex II): Recall - Presence of Particulate Matter
Particulate matter could potentially serve as a focal point for infection should any pre-existing peritonitis exist, and may lead to a fatal outcome. (Source: FDA MedWatch)
Source: FDA MedWatch - August 15, 2014 Category: American Health Source Type: news
