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Diagnostic Imaging Tray (Centurion) – Particulate Contamination (2014)

According to the recall notice received from Hospira, the recall was initiated due to a confirmed customer report of particulate in a single unit. Hospira identified the particulate as human hair, embedded in and attached to a pinched area of the stopper.

Class IIModerate

FDAOct 23, 2014Nationwide• Centurion Medical Products Corporation

GDC-10 360 SOFT Coils (Stryker) – Expiration Date Concern (2014)

Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.

Class IIModerate

FDAOct 22, 2014

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Diagnostic Imaging Tray (Centurion) – Particulate Contamination (2014)

GDC-10 360 SOFT Coils (Stryker) – Expiration Date Concern (2014)

Philips Expression MR200 (Invivo) – Power Test Failure (2014)

BiliVen Capsules (Premier Research Labs) – Undeclared Wheat (2014)

Quantum Gallbladder Support (Premier Research Labs) – Undeclared Wheat (2014)

Target 360 Standard Coils (Stryker) – Expiration Date Concern (2014)

Gateway PTA Balloon Catheter (Stryker) – Expiration Date Concern (2014)

GDC-18 360 Coils (Stryker) – Expiration Date Concern (2014)

GDC-10 360 Coils (Stryker) – Expiration Date Concern (2014)

Mercaptopurine Tablets (Prometheus Labs) – dissolution failure (2014)

HomeChoice Cycler (Baxter) – Unintended Button Activation (2014)

Blue Corn Waffle Mix (Los Chileros) – Product Field Action (2014)

Green Chile Blue Cornbread (Los Chileros) – Product Field Action (2014)

Santa Fe Chile Seasoning (Los Chileros) – Product Field Action (2014)

Green Chile Stew (Los Chileros) – Product Field Action (2014)

Carne Adovada (Los Chileros) – Product Field Action (2014)

Vanilla Pro-Med Protein Shake (Health Wise) – Foreign Matter (2014)

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

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

Sopaipilla Mix (Los Chileros) – Product Field Action (2014)