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MectaLIF Oblique Handle (Medacta) – Incorrect Laser Marking (2014)

The MectaLIF Oblique Handle has the laser marking "MEDIAL" on the incorrect side and could result in incorrect insertion of the device during surgery.

Class IIModerate

FDAOct 21, 2014CA, CO, ID• Medacta Usa

Falope-Ring Band Applicator (Gyrus Acmi) – Sterile Packaging Risk (2014)

All packages of Falope Ring Band Applicator kits are being recalled due to compromises in sterile packaging that could be associated with bacterial contamination that might lead to patient infection.

Class IIModerate

FDAOct 21, 2014Nationwide• Gyrus Acmi, Incorporated

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MectaLIF Oblique Handle (Medacta) – Incorrect Laser Marking (2014)

Falope-Ring Band Applicator (Gyrus Acmi) – Sterile Packaging Risk (2014)

CT PICC Catheter (Pfm Medical) – Bacterial Endotoxin Limit (2014)

ASEPT Drainage Kit (Pfm Medical) – Bacterial Endotoxin Limit (2014)

CardioImmune XL Control (Microgenics) – Analyte Variation (2014)

Is-Mumps IgG Test Kit (Diamedix) – Diluent Contamination (2014)

Rapid Centesis Catheter (Pfm Medical) – Bacterial Endotoxin Limit (2014)

Thoracentesis Procedure Tray (Pfm Medical) – Bacterial Endotoxin Limit (2014)

ASEPT Drainage Bag (Pfm Medical) – Bacterial Endotoxin Limit (2014)

Micro Introducer Kit (Pfm Medical) – Bacterial Endotoxin Limit (2014)

HemoCue Glucose Microcuvettes (Radiometer) – Shelf Life Issue (2014)

ASEPT Pleural Drainage System (Pfm Medical) – Bacterial Endotoxin Limit (2014)

Is-EBV-EA-D IgG Test Kit (Diamedix) – Diluent Contamination (2014)

Is-EBV-VCA IgG Test Kit (Diamedix) – Diluent Contamination (2014)

ASEPT Peritoneal Drainage System (Pfm Medical) – Bacterial Endotoxin Limit (2014)

La Fe Green Hot Sauce (Le Fe Foods) – Undeclared Colors (2014)

Veta Peritoneal Catheter (Pfm Medical) – Bacterial Endotoxin Limit (2014)

ThermoCool SmartTouch Catheters (Biosense) – Labeling Update (2014)

Total Temporomandibular Joint Replacement (Biomet) - Laser Etching Issue (2014)

Obagi Nu-Derm Clear (Obagi Medical) – Labeling Mix-Up (2014)