Archive | April, 2010
McNeil Consumer Healthcare Over-the-Counter Infants’ and Children’s Products: Recall
Certain over-the-counter Children’s and Infants’ liquid products may not meet required quality standards.
Continue reading...Cardiac Science Automated External Defibrillators – Powerheart, Cardiovive, NK, Responder models: Class I Recall
27. April 2010
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UPDATED 04/27/2010. FDA’s review of updated software indicates that it detects some but not all electrical component defects. Originally posted 03/08/2010
Continue reading...Covidien Initiates Voluntary Recall of Certain Shiley™ Tracheostomy Tubes
24. April 2010
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Recall due to the product’s cuff not holding air as a result of leaks in the pilot balloon inflation assembly.
Continue reading...LIFEPAK 15 Monitor/Defibrillator by Physio-Control Inc.
22. April 2010
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Class I Recall issued because of the potential for the device to expectedly power off and/or power on.
Continue reading...Propylthiouracil
21. April 2010
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[Updated 04/21/2010] FDA added a Boxed Warning to the label for propylthiouracil,to include information about reports of severe liver injury and acute liver failure, some of which have been fatal, in adult and pediatric patients.
Continue reading...Atlas Operations, Inc.: Recall of Sexual Enhancement Products
14. April 2010
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[UPDATED 04/14/2010] Recall expanded to include additional products, sold as a dietary supplements, containing undeclared sulfoaildenafil, which may result in lowering of blood pressure to dangerous levels. Originally posted 12/15/2009
Continue reading...Teleflex Arrow IV Tubing Sets, Accessories, and Embolectomy Catheters: Recall
8. April 2010
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UPDATE 04/08/2010. Recall has been classified as Class I. Product sterility cannot be guaranteed. Originally posted 03/16/2010
Continue reading...Camolyn eye drops, Fisiolin nasal drops: Voluntary recall due to non-sterility
7. April 2010
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Lack of sterile product has the potential to cause infections.
Continue reading...Heparin: Change in Reference Standard
7. April 2010
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New studies reinforce FDA’s previous recommendation for healthcare professionals to exercise clinical judgment in determining the dose of heparin for a patient.
Continue reading...Stud Capsule For Men: Product contains Undeclared Drug Ingredient
6. April 2010
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Product adulterated with sildenafil which may interact with nitrates to lower blood pressure to dangerous levels.
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30. April 2010
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