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Showing 8141–8160 of 8393 results

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Gentell, Inc: Gentell Honey Hydrogel 4"x8" Saturated Gauze- A hydrating...

During an FDA audit, it was discovered that the product was not properly registered with FDA.

FDAMar 26, 2020Nationwide• Gentell, Inc

Gentell, Inc: Gentell Honey Hydrogel 4"x4" Saturated Gauze- A hydrating...

During an FDA audit, it was discovered that the product was not properly registered with FDA.

FDAMar 26, 2020Nationwide• Gentell, Inc

Abbott Diagnostics Technologies AS Kjelsaasveien: Power supply provided with Afinion 2, Catalog numbers 111...

The analyzer system may have an electrostatic discharge and sparking of the power supply provided with the analyzers resulting in the power supply becoming non-functional.

FDAMar 23, 2020GA, NJ• Abbott Diagnostics Technologies AS Kjelsaasveien

LeMaitre Vascular, Inc.: LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Mode...

There has been an increased trend in reports of catheters failing to deflate during use, which may ultimately lead to tip separation.

FDAMar 23, 2020Nationwide• LeMaitre Vascular, Inc.

Smith & Nephew, Inc.: Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 Part...

Space between the device and the packaging permits excessive movement which could potentially lead to the displacement of the anchors tip protector allowing the tip of the anchor to create a sterile breach.

FDAMar 17, 2020Nationwide• Smith & Nephew, Inc.

Rayner Intraocular Lenses Limited The Ridley Innovation Centre 10 Dominion Way Worthing United Kingdom: RaySert PLUS RSP01. LOT K030. Expiry of 2024-01 - Product...

RaySert PLUS RSP01 LOT K030 labeled with an expiry of 2024-01 contained an inner tray that was labeled with an expiry of 2015. In addition to having an expiry of 2015 the LOT number on the inner tray is identified as V001.

FDAMar 17, 2020Nationwide• Rayner Intraocular Lenses Limited The Ridley Innovation Centre 10 Dominion Way Worthing United Kingdom

Fresenius Medical Care Holdings, Inc.: Fresenius 2008T Hemodialysis Machine: Part Number Descri...

A "Remove USB Device 2" false alarm may be displayed when no USB device or a non-powered USB device is connected to the USB port on the rear of the machine

FDAMar 12, 2020Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: Fresenius 2008T BlueStar Hemodialysis Machine Part Num...

A "Remove USB Device 2" false alarm may be displayed when no USB device or a non-powered USB device is connected to the USB port on the rear of the machine

FDAMar 12, 2020Nationwide• Fresenius Medical Care Holdings, Inc.

Biomerieux Inc: The VITEK 2 Gram-positive Susceptibility Card is intended...

There is a potential for the occurrence of false positive OXSF results for some Staphylococcus aureus strains in conjunction with the VITEK 2 AST-P652 test card (ref. 421857, lot 8021232403). .

FDAMar 11, 2020Nationwide• Biomerieux Inc

Boston Scientific: Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX ST...

An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

FDAMar 9, 2020Nationwide• Boston Scientific

Boston Scientific: Polaris Ultra Ureteral Stent Set 6FX24CM with .035 Sensor...

An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

FDAMar 9, 2020Nationwide• Boston Scientific

Boston Scientific: Stretch VL Ureteral Stent Set 4.8FX22-30CM with .035 Sen...

An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

FDAMar 9, 2020Nationwide• Boston Scientific

Boston Scientific: Percuflex Plus Ureteral Stent Set 6FX24CM with .038 Senso...

An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

FDAMar 9, 2020Nationwide• Boston Scientific

Boston Scientific: Contour VL Ureteral Stent Set 6FX22-30CM with .035 Sensor...

An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

FDAMar 9, 2020Nationwide• Boston Scientific

Linet Americas: AVE 2 Birthing Bed - Product Usage: is designated to be u...

The UDI on the device label indicates incorrect manufacturer.

FDAMar 6, 2020Nationwide• Linet Americas

Radiometer Medical ApS Akandevej 21 Bronshoj Denmark: ABL800 FLEX model number 393-800 and 393-801, UDI:(01)057...

Through internal investigation is has been determined that an incorrect component was used within the power supply. The incorrect component may cause a short circuit within the power supply resulting in a delay in treatment. The delay could result in a range of risk from cyanosis and low blood pressure to cardiac arrhythmias and severe impairment of cardiac function.

FDAMar 6, 2020CA, IN• Radiometer Medical ApS Akandevej 21 Bronshoj Denmark

Respironics California, LLC: Philips V60 Ventilators with Power Management PCBA part n...

Solder connection failure on Power Management printed circuit board assembly of ventilators may cause 1) Blower to lose power, spool down, and trigger visual and audible High Priority Check Vent alarm indicating a need for alternative ventilation, or 2) Intermittent connection may disrupt expected operation and trigger unexpected shutdown without alarm. Failures may lead to hypercarbia/hypoxemia

FDAMar 5, 2020AL, AK, AZ +49 more• Respironics California, LLC

Skytron, Div. The KMW Group, Inc: Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen...

Potential for the weld to fail at the pivot point of the monitor bracket. This weld failure could cause the display interface and bracket to fall from its mounted location, resulting in injury.

FDAMar 5, 2020AZ, CO, GA +7 more• Skytron, Div. The KMW Group, Inc

RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden: RayStation standalone software treatment planning system,...

Due to physical limitations of the treatment machine, the maximum field opening for Siemens Virtual Wedge fields recommended by the LINAC vendor will be more restricted in the wedged direction than the maximum field opening without a wedge. Delivering a larger field opening with a virtual wedge will not result in a wedged field shape over the entire field. Instead, a high dose plateau region will be the result at the toe side of the field beyond the recommended field size.

FDAMar 4, 2020Nationwide• RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden

Canon Medical System, USA, INC.: Infinix-8000C with Catheterization Table CAT-850B or CAT-...

Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.

FDAMar 3, 2020Nationwide• Canon Medical System, USA, INC.

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