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Operating Room Table (IMRIS) – Missing Pin (2014)

One of the three pins that is used to hold the ORT200 table alignment block in place on the floor of the MR Suite went missing during testing at a health care facility.

Class IIModerate

FDAOct 1, 2014CA, FL, NH +3 more• IMRIS Inc

Organic Product (Multiple Organics) – Metal Fragment Risk (2014)

Firm was notified that the product may contain fragments of metal that if ingested, may be injurious to human health. Firm has not been able to independently verify the reports, but believes it prudent to take this action.

Class IIModerate

FDASep 30, 2014Nationwide• Multiple Organics, Inc.

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Operating Room Table (IMRIS) – Missing Pin (2014)

Organic Product (Multiple Organics) – Metal Fragment Risk (2014)

StarMedTec LightTrail Fibers 365um (Boston Scientific) – Laser Compatibility (2014)

Elk Shaped Wholemeal Pasta (Ikea) – Undeclared Soy (2014)

Dimension HB1C Flex (Siemens) – Hemoglobin Bias (2014)

StarMedTec LightTrail Fibers 600um (Boston Scientific) – Laser Compatibility (2014)

SET uSpO2 Cable (Masimo) – Crossed Wires (2014)

Symmetric Total Knee Components (Signal Medical) – Packaging Issue (2014)

StarMedTec LightTrail Fibers 800um (Boston Scientific) – Laser Compatibility (2014)

Elk Shaped Pasta (Ikea) – Undeclared Soy (2014)

Selector Kit (Integra) – Irrigation Fluid Leak (2014)

ASTS-LG1212 Spine Truss (4-Web) – Mislabeling (2014)

Cavity Varnish (Dharma Research) – Unapproved Marketing (2014)

DOPamine Hydrochloride Injection (Baxter) – Sterility Risk (2014)

Vanilla Cookies (Oro Candy) – Undeclared Color Additives (2014)

Conveen Urine Collection Leg Bag (Coloplast) – Potential Leakage (2014)

Cavity Varnish with Fluoride (Dharma Research) – Unapproved Marketing (2014)

CADD-Solis Medication Software (Smiths Medical) – Batch Issue (2014)

Merge Hemo Computer (Merge Healthcare) – SpO2 Display Problem (2014)

Dark Chocolate Cherries (Tropical Valley) – Undeclared Peanuts (2014)