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Vision Assure Supplement (Formulations) - Manufacturing Issue (2014)

Formulations For Life has recalled 3 varieties of Dietary Supplements due to lack of Good Manufacturing Practices and misbranding.

Class IIModerate

FDASep 24, 2014NY, PA• Formulations For Life

SOUNDSTAR eco Catheters (Sterilmed) – Unspecified Issue (2014)

Sterilmed, a division of Johnson & Johnson Medical NV/SA (Sterilmed), has become aware of an issue affecting certain lots of Reprocessed SOUNDSTAR® eco Diagnostic Ultrasound Catheters for which Sterilmed is the reprocessor and Biosense Webster is the distributor. Sterilmed determined that the units of these lots were incorrectly processed and as a result when the affected catheter is conne

Class IIModerate

FDA

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Vision Assure Supplement (Formulations) - Manufacturing Issue (2014)

SOUNDSTAR eco Catheters (Sterilmed) – Unspecified Issue (2014)

EasyCare Bed (Joerns) – Care-Lock System (2014)

Resevera Action Dietary Supplement (Formulations) - Manufacturing Issue (2014)

MultiDiagnost Foot Switches (Philips) – Key Image Functionality (2014)

Gene Strength Supplement (Formulations) - Manufacturing Issue (2014)

Bone Level Implant (Straumann) – Incorrect Transfer Piece (2014)

Dimension Phenytoin Flex (Siemens) – Calibration Range (2014)

Discovery Elbow Humeral Trial (Biomet) – Incorrect Marking (2014)

Allura Xper Foot Switches (Philips) – Key Image Functionality (2014)

Lobster Bisque (Original Soup Man) - Undeclared Seafood (2014)

ArcPoint 5 Panel Drug Screen (Ameditech) – Incorrect Label (2014)

ArcPoint 10 Panel Drug Screen (Ameditech) – Incorrect Label (2014)

Perfecto 2 V Oxygen Concentrator (Invacare) – Sieve Bed Defect (2014)

Artis Zeego System (Siemens) – Cable Routing Issue (2014)

Microseal Augmented Liner (Signal Medical) – Dimension Error (2014)

ArcPoint 10 Panel Drug Screen OXY (Ameditech) – Incorrect Label (2014)

GMK Intramedullary Extension Rod (Medacta) – Rod Breakage Risk (2014)

Losartan Potassium Tablets (Micro Labs) – Uniformity Failure (2014)

Cephalexin Capsules (Physicians Total Care) – Manufacturing Deviation (2014)