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Showing 7801–7820 of 8393 results

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Boston Scientific Corporation: Captivator Single-Use Polypectomy Snares, Captiflex Singl...

Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.

FDAJan 19, 2021Nationwide• Boston Scientific Corporation

Hamilton Co: HAMILTON HEATER SHAKER, 115 VAC/ 230 VAC, 750 VA, Power C...

There is a risk that the device can start a fire if flammable liquids contact and enter the device.

FDAJan 15, 2021AL, AZ, AR +41 more• Hamilton Co

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.): CervAlign Anterior Cervical Plate System-Cervalign, 1 Lev...

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

FDAJan 15, 2021Nationwide• RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Physio-Control, Inc.: PHYSIO CONTROL LIFEPAK CR2 Defibrillator 3321605-xxx T...

Due to complaints received regarding missing lid magnets which may result in premature battery depletion.

FDAJan 14, 2021Nationwide• Physio-Control, Inc.

Medical Components, Inc dba MedComp: Power Injectable CT Port insertion kits - Product Usage: ...

The 5F Dignity CT Port kits were packaged with the incorrect size port. The kits include a 6.6F port instead of the correct 5F port. The inability to connect the catheter lumen to the port stem because of the incorrect size may not be noted until well into the procedure, after the catheter lumen is placed in the vessel. An alternate port will need to be obtained prolonging the procedure. A prolonged insertion procedure increases any risk associated with a surgical procedure.

FDAJan 13, 2021Nationwide• Medical Components, Inc dba MedComp

Medtronic Neurosurgery: Medtronic Delta CSF (Cerebro Spinal Fluid) -Flow Control...

Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus

FDAJan 11, 2021Nationwide• Medtronic Neurosurgery

Medtronic Neurosurgery: Medtronic Cerebro Spinal Fluid Flow Control Valves and ...

Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus

FDAJan 11, 2021Nationwide• Medtronic Neurosurgery

Medtronic Neurosurgery: Medtronic PS Medical Cerebro Spinal Fluid (CSF)-Flow Con...

Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus

FDAJan 11, 2021Nationwide• Medtronic Neurosurgery

Nihon Kohden America Inc: WMTS Telemetry Receiver, Multiple Patient Receiver, Mode...

Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter.

FDAJan 8, 2021AL, AZ, AR +43 more• Nihon Kohden America Inc

Cardinal Health 200, LLC: Lab Coats SMS Medium White, SKU 2301LC Cardinal Health I...

There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.

FDAJan 7, 2021Nationwide• Cardinal Health 200, LLC

Cardinal Health 200, LLC: Gown Isolation W/Ties Xl Blue, SKU 2201PG Cardinal Healt...

There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.

FDAJan 7, 2021Nationwide• Cardinal Health 200, LLC

Cardinal Health 200, LLC: Gown Isolation W/Ties Univ Blu, SKU 1200PG, 2200PG, 55220...

There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.

FDAJan 7, 2021Nationwide• Cardinal Health 200, LLC

Cardinal Health 200, LLC: Lab Coats SMS Large White, SKU 2302LC Cardinal Health Is...

There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.

FDAJan 7, 2021Nationwide• Cardinal Health 200, LLC

Cardinal Health 200, LLC: Lab Coats SMS X-Large Blue, SKU 2203LC Cardinal Health I...

There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.

FDAJan 7, 2021Nationwide• Cardinal Health 200, LLC

Cardinal Health 200, LLC: Gown Isolation W/Ties Univ Ylw, SKU 1100PG, V1100PG, 2100...

There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.

FDAJan 7, 2021Nationwide• Cardinal Health 200, LLC

Cardinal Health 200, LLC: Lab Coats SMS 2X-Large White, SKU 2304LC Cardinal Health...

There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.

FDAJan 7, 2021Nationwide• Cardinal Health 200, LLC

Cardinal Health 200, LLC: Gown Kendall Blue RG, SKU CT5000 Cardinal Health Isolati...

There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.

FDAJan 7, 2021Nationwide• Cardinal Health 200, LLC

Cardinal Health 200, LLC: Gown Kendall Blue XXL, SKU CT5102 Cardinal Health Isolat...

There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.

FDAJan 7, 2021Nationwide• Cardinal Health 200, LLC

Cardinal Health 200, LLC: Lab Coats SMS 2X-Large Blue, SKU 2204LC Cardinal Health ...

There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.

FDAJan 7, 2021Nationwide• Cardinal Health 200, LLC

Cardinal Health 200, LLC: Lab Coats SMS Large Blue, SKU 2202LC Cardinal Health Iso...

There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.

FDAJan 7, 2021Nationwide• Cardinal Health 200, LLC

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