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covidien llc

6 recalls on record

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Covidien LLC — Covidien Mon-a-Therm General Purpose Temperature Probe REF: 90044

Temperature probe devices lack FDA clearance.

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Covidien LLC — Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050

Temperature probe devices lack FDA clearance.

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Covidien LLC — Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Codes that include the Covidien Shiley Disposable Decannulation Plug are: Product Numbe

Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.

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Covidien LLC — Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042

Temperature probe devices lack FDA clearance.

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Covidien LLC — COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are intended for use in providing tracheal access for airway management.

Due to customer complaint regarding incorrect display box labeling.

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Covidien LLC — HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes: Vital Sync 3.3.1 / 10884521844933 Vital

Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system.