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Showing 10861–10880 of 11714 results

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Stimwave Technologies Inc: StimQ Peripheral Nerve Stimulator System (PNS) Model 1. S...

The product contains a non-functional component not referenced in product labeling.

FDAJul 15, 2020Nationwide• Stimwave Technologies Inc

Thomas Scientific: Wuxi Nest, model numbers 202115, 202117, 202017, 202018 -...

The firm is replacing all tubes that were manufactured and distributed prior to Enforcement Discretion Approval.

FDAJul 14, 2020Nationwide• Thomas Scientific

Canon Medical System, USA, INC.: System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Mode...

During a procedure, when images were acquired, and these images were transferred to PACS /image archival system, the number of images displayed were not the same as originally acquired.

FDAJul 8, 2020CA, CT, ID +7 more• Canon Medical System, USA, INC.

OrthoPediatrics Corp: Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The...

Product may have incorrect laser etched alignment lines, the non-conforming laser etch may have compromised strength, lead to unintended fracture of the device

FDAJul 6, 2020Nationwide• OrthoPediatrics Corp

Boston Scientific Corporation: Captivator Polypectomy Snare, Single-Use Polypectomy Snar...

Laceration Risk

BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, tissue damage and/or self-limited bleeding. The most severe potential injury would include immediate or delayed hemorrhage and/or perforation requiring intervention up to and including open surgery; the likelihood of these severe injuries occurring is remote and, to date, have not been reported as a complaint. The potential inability to cut may also lead to inadequate removal of target tissue.

FDAJul 6, 2020Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Captiflex Snares, Single-Use Polypectomy Snare consists o...

Laceration Risk

BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, tissue damage and/or self-limited bleeding. The most severe potential injury would include immediate or delayed hemorrhage and/or perforation requiring intervention up to and including open surgery; the likelihood of these severe injuries occurring is remote and, to date, have not been reported as a complaint. The potential inability to cut may also lead to inadequate removal of target tissue.

FDAJul 6, 2020Nationwide• Boston Scientific Corporation

Dynex Technologies, Inc.: DYNEX Agility, Agility Analyzer, Model No. 67000

Control samples aspirated from wrong SmartKit on the Agility. Agility software was updated to v1.4.7 to resolve the issue. This leads to a risk that a control from another assay's SmartKit will be used instead of the correct control, which may lead to delayed patient results.

FDAJul 5, 2020Nationwide• Dynex Technologies, Inc.

Metformin Hydrochloride Extended-Release 750mg (Granules) – NDMA Impurity (2020)

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Class IIModerate

FDAJul 3, 2020Nationwide• Granules Pharmaceuticals Inc

TELEFLEX MEDICAL INC: Pleur-Evac Adult-Ped Wet, LF Eng/Spanish, product code: A...

Potential for sterile packaging to be compromised

FDAJun 30, 2020Nationwide• TELEFLEX MEDICAL INC

TELEFLEX MEDICAL INC: Pleur-Evac Adult-Ped Wet, LF Intl Eng, product code: A-80...

Potential for sterile packaging to be compromised

FDAJun 30, 2020Nationwide• TELEFLEX MEDICAL INC

CareFusion 303, Inc.: Alaris PCA Module Model 8120 - Product Usage: is intended...

LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.

FDAJun 30, 2020Nationwide• CareFusion 303, Inc.

CareFusion 303, Inc.: Alaris Pump Module Model 8100 - Product Usage: is intende...

LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.

FDAJun 30, 2020Nationwide• CareFusion 303, Inc.

Medline Industries Inc: ClearPro Trach T-Piece Closed Suction Catheter, Model DYN...

There are reports of the suction catheter coming apart from the device assembly during use.

FDAJun 30, 2020Nationwide• Medline Industries Inc

CareFusion 303, Inc.: Alaris Syringe Module Model 8110 - Product Usage: is inte...

LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.

FDAJun 30, 2020Nationwide• CareFusion 303, Inc.

CareFusion 303, Inc.: Alaris EtCO2 Module Model 8300 - Product Usage: is intend...

LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.

FDAJun 30, 2020Nationwide• CareFusion 303, Inc.

CareFusion 303, Inc.: Alaris SpO2 Module Model 8210 and Model 8220 - Product Us...

LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.

FDAJun 30, 2020Nationwide• CareFusion 303, Inc.

Medline Industries Inc: ClearPro T-Piece Closed Suction Catheter, Model DYNCPTP14...

There are reports of the suction catheter coming apart from the device assembly during use.

FDAJun 30, 2020Nationwide• Medline Industries Inc

Smiths Medical ASD Inc.: Medfusion Syringe Pump Model 4000; Software Versions V1.5...

Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.

FDAJun 26, 2020Nationwide• Smiths Medical ASD Inc.

Smiths Medical ASD Inc.: Medfusion Syringe Pump Model 3500, Software Version V6.0....

Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.

FDAJun 26, 2020Nationwide• Smiths Medical ASD Inc.

Precision Valve & Automation, Inc: PVA, PREVENT is an FDA-authorized emergency ventilator de...

While operating the machine in "Run" mode an unexcepted event may occur during the error-checking for stepper movements and pressure values. The result of this event is a false alarm being thrown and in rare cases results in an incomplete move which will affect the current inhale/exhale cycle.

FDAJun 26, 2020Nationwide• Precision Valve & Automation, Inc

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