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Showing 6801–6820 of 11714 results

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IMPIX MANTA (Medicrea) – Packaging Pinhole Issue (2023)

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

FDAJul 12, 2023Nationwide• Medicrea International Vancia Vancia Rillieux La Pape France

PASS LP (Medicrea) – Packaging Pinhole Issue (2023)

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

FDAJul 12, 2023Nationwide• Medicrea International Vancia Vancia Rillieux La Pape France

Air/Water Valve (Olympus) – Valve Functionality Loss (2023)

The air/water valve MAJ-1444 used with OER-Pro and OER-Elite may become damaged and result in loss of the one-way valve functionality by repeated automated endoscope reprocessing in Olympus OER machines, causing body fluid could backflow into the air/water channel of the ultrasonic endoscopes during the procedure.

High

FDAJul 12, 2023Nationwide• Olympus Corporation of the Americas

IMPIX MANTA+, REF numbers: a) B20171743, b) B20171753,... (Medicrea International Vancia Vancia Rillieux La Pape France) – there is a potential for a product pa... (2023)

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

FDAJul 12, 2023Nationwide• Medicrea International Vancia Vancia Rillieux La Pape France

Carina Sub-Acute Care Ventilator (Draeger Medical, Inc.) – presence of polyether polyurethane (p... (2023)

Presence of polyether polyurethane (PE-PUR) and emission of 1,3-Dichloropropan-2-ol that exceed the acceptable uptake level during continuous use (>30 days) in pediatric patients.

FDAJul 12, 2023Nationwide• Draeger Medical, Inc.

The following Pro.specta Emission Computed Tomography Sys... (Siemens Medical Solutions USA, Inc.) – during a whole-body planar scan with ... (2023)

During a whole-body planar scan with auto-contour, there is a possibility the short-linear drive (SLD) look-ahead sensors may trigger earlier than expected and may result in detector 1 positioning further from the patient than needed leading to a reduction in image resolution.

FDAJul 12, 2023ID, KS, MA +4 more• Siemens Medical Solutions USA, Inc.

CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K (Medtronic Sofamor Danek USA, Inc) – incorrect laser marking - solera awl ... (2023)

Incorrect Laser Marking - Solera Awl Tip Tap

FDAJul 12, 2023Nationwide• Medtronic Sofamor Danek USA, Inc

GRANVIA-C (Medicrea) – Packaging Pinhole Issue (2023)

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

FDAJul 12, 2023Nationwide• Medicrea International Vancia Vancia Rillieux La Pape France

IMPIX TLIF (Medicrea) – Packaging Pinhole Issue (2023)

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

FDAJul 12, 2023Nationwide• Medicrea International Vancia Vancia Rillieux La Pape France

FreeStyle Libre 2 Readers (Abbott) – Sensor Start Issue (2023)

If blood glucose monitoring system users attempt to start a new sensor, when the old sensor wasn't used for the full 14-day wear time, then the reader may display "Incompatible Sensor" message. If users don't have the previous sensor, or FreeStyle Libre 2 app, or the sensor's full wear time hasn't ended, users may be unable to start a new sensor, which could result in no or delayed glucose results

FDAJul 12, 2023Nationwide• Abbott Diabetes Care, Inc.

IMPIX ALIF (Medicrea) – Packaging Pinhole Issue (2023)

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

FDAJul 12, 2023Nationwide• Medicrea International Vancia Vancia Rillieux La Pape France

IMPIX ALIF S/A (Medicrea) – Packaging Pinhole Issue (2023)

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

FDAJul 12, 2023Nationwide• Medicrea International Vancia Vancia Rillieux La Pape France

IMPIX DLIF (Medicrea) – Packaging Pinhole Issue (2023)

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

FDAJul 12, 2023Nationwide• Medicrea International Vancia Vancia Rillieux La Pape France

IMPIX C+ (Medicrea) – Packaging Pinhole Issue (2023)

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

FDAJul 12, 2023Nationwide• Medicrea International Vancia Vancia Rillieux La Pape France

IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c... (Medicrea International Vancia Vancia Rillieux La Pape France) – there is a potential for a product pa... (2023)

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

FDAJul 12, 2023Nationwide• Medicrea International Vancia Vancia Rillieux La Pape France

Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x (Beckman Coulter Inc.) – lipemic interference failed to meet t... (2023)

Lipemic interference failed to meet the performance specification listed within the IFU.

FDAJul 12, 2023AL, AZ, AR +40 more• Beckman Coulter Inc.

EMBLEM MRI S-ICD Pulse Generator Model A219; Subcutaneous... (Boston Scientific Corporation) – there is a potential for a rare inter... (2023)

There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour interval.

FDAJul 11, 2023Nationwide• Boston Scientific Corporation

EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Imp... (Boston Scientific Corporation) – there is a potential for a rare inter... (2023)

There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour interval.

FDAJul 11, 2023Nationwide• Boston Scientific Corporation

Oxacillin Injection (Sagent) – sterility issue (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 11, 2023Nationwide• Sagent Pharmaceuticals

Oxacillin Injection (Sagent) – sterility risk (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 11, 2023Nationwide• Sagent Pharmaceuticals

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