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Sunscreen
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Questions and Answers: FDA announces new requirements for over-the-counter (OTC) sunscreen products marketed in the U.S.
On June 14, 2011 the U.S. Food and Drug Administration (FDA) announced new requirements for sunscreens currently sold over-the-counter (OTC) (i.e. non-prescription). These requirements support the Agency’s ongoing efforts to ensure that sunscreens meet modern-day standards for safety and effectiveness. The new requirements, as well as several proposed changes for future rules, are outlined in…
Class I Medical Device Recall: Terumo Coronary Ostia Cannula 10, 12, 14 Fr
Recall Class: Class I Date Recall Initiated: May 16, 2011 Product(s): Coronary Ostia Cannula 10 (25 cm) long, model numbers 804115, 804117, 804159, all lot/serial numbers. 6,220 devices are subject to this recall. Terumo Cardiovascular Systems Corporation (Terumo CVS) decided to remove the product line from the market and discontinue further supply. The company notified…
Class I Medical Device Recall: Maquet Datascope Corp. Intra-Aortic Balloon Pumps
Recall Class: Class I Date Recall Initiated: March 16, 2011 Product(s): System 98/98XT, CS100/CS100i and CS300 Intra-Aortic Balloon Pumps manufactured between May2008 and December 2010. 885 devices are subject to this recall. Affected lot/serial numbers include 7081436, 7081963, 7083463, and 7090616. Affected models: 0998-00-0446-xx 0998-UC-0446-xx 0998-00-0479-xx 0998-UC-0479-xx 0998-UC-0446Hxx 0998-UC-0479Hxx 0998-00-3013-xx 0998-UC-3013-xx 0998-00-3023-xx 0998-UC-3023-xx Maquet Datascope…
Class I Medical Device Recall: Boston Scientific iCross and Atlantis SR Pro 2 Coronary Imaging Catheters
Recall Class: Class I Date Recall Initiated: March 28, 2011 Product(s): iCross and Atlantis A Pro2, 40 Mhz Coronary Imaging Catheter, 3.6F (1.18mm) x 135 cm, all lots. 110,020 devices are subject to this recall. iCross is marketed within the United States and its territories. Atlantis SR Pro2 is distributed outside the U.S. Boston Scientific…
FluLaval
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Maquet Datascope Corp. Intra-Aortic Balloon Pumps: Recall – Shuts Off Without Warning
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Terumo Coronary Ostia Cannula 10, 12, 14 Fr: Recall – Fragments of Adhesive and Plastic in the Cannula Tip May Embolize
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Risperidone (Risperdal) and Ropinirole (Requip): Medication Errors
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