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Valved Tearaway Kit (Galt) – Adhesive Embolic Risk (2014)

The adhesive used in the product could dislodge when objects are inserted through the valve which could pose an embolic risk to the patient.

Class IIModerate

FDAJul 25, 2014Nationwide• Galt Medical Corporation

Ultra Battery 1 (Estill Medical) – Charging Performance (2014)

Estill has discovered that a fully discharged Ultra Battery 1 (TA-UB1) will reach 96.9% of its capacity during a 60 minute charging period. If you have a fully discharged Ultra Battery 1 (TA-UB1), in order to achieve a 100% of charge capacity you should charge it for a period of 90 minutes. In addition, the charging voltage range of 10-36V specified on the Ultra Battery 1 (TA-UB1) label and in t

Class IIModerate

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Valved Tearaway Kit (Galt) – Adhesive Embolic Risk (2014)

Ultra Battery 1 (Estill Medical) – Charging Performance (2014)

Sun Dash Radius 252 (JK Products) – Wire Integrity Risk (2014)

Alprazolam Tablets (Sandoz) – metal particulates (2014)

IntelliSpace PACS 4.4 (Philips) – Header Change Error (2014)

Phytobase Cream (Fagron) – mold contamination (2014)

Pentravan Base (Fagron) – mold contamination (2014)

Metoprolol Succinate Tablets (Wockhardt) – dissolution failure (2014)

MacroBar Sunflower Butter + Chocolate (GoMacro) – undeclared ingredient (2014)

T2 Tibia System Nail Sleeve (Stryker) – Dimensional Mismatch (2014)

Pentravan Plus Base (Fagron) – mold contamination (2014)

Grilled Salmon with Peach Ginger Jam (Whole Foods) – Listeria contamination (2014)

Peach Cobbler (Whole Foods Market) - Listeria contamination (2014)

Cumin Lime Peach Mozzarella Towers (Whole Foods Market) – Listeria Risk (2014)

Grilled Peaches and Cream (Whole Foods Market) – Listeria Risk (2014)

Dess Bar-Peach Crumble (Whole Foods Market) – Listeria risk (2014)

Fruit Kabobs for Grilling (Whole Foods Market) – Listeria risk (2014)

Peaches Cream Cake (Whole Foods Market) – Listeria Risk (2014)

Cake Slice Chantilly (Whole Foods Market) – Listeria risk (2014)

Peach Nectarine Lemonade (Whole Foods Market) – Listeria risk (2014)