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Showing 4981–5000 of 8393 results

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PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x1... (TEI Biosciences, Inc.) – possible out of specification endotox... (2023)

Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

FDAMay 23, 2023Nationwide• TEI Biosciences, Inc.

SurgiMend; Collagen Matrix for Soft Tissue Reconstruction... (TEI Biosciences, Inc.) – possible out of specification endotox... (2023)

Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

FDAMay 23, 2023Nationwide• TEI Biosciences, Inc.

SurgiMend 1.0; Collagen Matrix for Soft Tissue Reconstruc... (TEI Biosciences, Inc.) – possible out of specification endotox... (2023)

Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

Low

FDAMay 23, 2023Nationwide• TEI Biosciences, Inc.

wDR 2.2 Mobile Digital Diagnostic X-Ray System (SEDECAL SA PELAYA, 9 POL. POL. IND. RIO DE JANEIRO Algete Spain) – there is a software login in issue th... (2023)

There is a software login in issue that may prevent the user from logging in.

FDAMay 23, 2023Nationwide• SEDECAL SA PELAYA, 9 POL. POL. IND. RIO DE JANEIRO Algete Spain

PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only... (TEI Biosciences, Inc.) – possible out of specification endotox... (2023)

Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

FDAMay 23, 2023Nationwide• TEI Biosciences, Inc.

SurgiMend 4.0; Collagen Matrix for Soft Tissue Reconstruc... (TEI Biosciences, Inc.) – possible out of specification endotox... (2023)

Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

FDAMay 23, 2023Nationwide• TEI Biosciences, Inc.

Revize; Collagen Matrix for Soft Tissue Reconstruction; R... (TEI Biosciences, Inc.) – possible out of specification endotox... (2023)

Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

FDAMay 23, 2023Nationwide• TEI Biosciences, Inc.

SurgiMend 2.0; Collagen Matrix for Soft Tissue Reconstruc... (TEI Biosciences, Inc.) – possible out of specification endotox... (2023)

Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

FDAMay 23, 2023Nationwide• TEI Biosciences, Inc.

DiagnosUS Pregnancy Test Midstream REF 100-17 (Universal Meditech Inc.) – universal meditech inc (2023)

Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is also recall their tests because they are going out of business and would not be able to continue fulfilling any post-market responsibilities of these distributed products. UMI claims to hold 510(k)s for the other devices, purchased the intellectual property in 2015 from the previous 510(k) holder, but FDA has been unable to verify this information. The devices may have unknown performance characteristics because the firm is unable to provide any documentation that the devices were manufactured in conformance with the Quality System regulation, including documentation (e.g., DHF) that the distributed devices had not been modified since original clearance in a way that could impact their safety and effectiveness, documentation of controlled storage temperature/humidity, and post-market surveillance documentation, such as complaints and adverse events.

FDAMay 22, 2023CA, FL, IL +5 more• Universal Meditech Inc.

Medtronic ILLUMISITE Platform Console, Model Number ILS-1... (Covidien, LLC) – single illumisite platform console wa... (2023)

Single ILLUMISITE Platform Console was converted from a 220-240VAC model to a 120VAC configuration using a non-supplied power cord and non-supplied fuses in the field by Medtronic Field Service Engineer.

FDAMay 22, 2023IN• Covidien, LLC

To Life hCG Pregnancy Urine Test Strips Format REF Cat No... (Universal Meditech Inc.) – universal meditech inc (2023)

Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is also recall their tests because they are going out of business and would not be able to continue fulfilling any post-market responsibilities of these distributed products. UMI claims to hold 510(k)s for the other devices, purchased the intellectual property in 2015 from the previous 510(k) holder, but FDA has been unable to verify this information. The devices may have unknown performance characteristics because the firm is unable to provide any documentation that the devices were manufactured in conformance with the Quality System regulation, including documentation (e.g., DHF) that the distributed devices had not been modified since original clearance in a way that could impact their safety and effectiveness, documentation of controlled storage temperature/humidity, and post-market surveillance documentation, such as complaints and adverse events.

FDAMay 22, 2023CA, FL, IL +5 more• Universal Meditech Inc.

BD Pyxis CII Safe, Software: V7, REF: 107-96, 107-97, 107... (CareFusion 303, Inc.) – shock hazard (2023)

Automated dispensing cabinet devices plugged into any multi-socket outlet power strips may present unacceptable levels of current leakage, which could expose users to system downtime and/or potential electric shock.

FDAMay 22, 2023Nationwide• CareFusion 303, Inc.

HealthyWiser KetoFast" Ketone Test Strips REF 900-1K 150... (Universal Meditech Inc.) – universal meditech inc (2023)

Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is also recall their tests because they are going out of business and would not be able to continue fulfilling any post-market responsibilities of these distributed products. UMI claims to hold 510(k)s for the other devices, purchased the intellectual property in 2015 from the previous 510(k) holder, but FDA has been unable to verify this information. The devices may have unknown performance characteristics because the firm is unable to provide any documentation that the devices were manufactured in conformance with the Quality System regulation, including documentation (e.g., DHF) that the distributed devices had not been modified since original clearance in a way that could impact their safety and effectiveness, documentation of controlled storage temperature/humidity, and post-market surveillance documentation, such as complaints and adverse events.

FDAMay 22, 2023CA, FL, IL +5 more• Universal Meditech Inc.

Lem Fertility LH Ovulation Test (Strip) REF 200-07 (Universal Meditech Inc.) – universal meditech inc (2023)

Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is also recall their tests because they are going out of business and would not be able to continue fulfilling any post-market responsibilities of these distributed products. UMI claims to hold 510(k)s for the other devices, purchased the intellectual property in 2015 from the previous 510(k) holder, but FDA has been unable to verify this information. The devices may have unknown performance characteristics because the firm is unable to provide any documentation that the devices were manufactured in conformance with the Quality System regulation, including documentation (e.g., DHF) that the distributed devices had not been modified since original clearance in a way that could impact their safety and effectiveness, documentation of controlled storage temperature/humidity, and post-market surveillance documentation, such as complaints and adverse events.

FDAMay 22, 2023CA, FL, IL +5 more• Universal Meditech Inc.

HealthyWiser UriTest" UTI Test Strips REF 900-UTI (Universal Meditech Inc.) – universal meditech inc (2023)

Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is also recall their tests because they are going out of business and would not be able to continue fulfilling any post-market responsibilities of these distributed products. UMI claims to hold 510(k)s for the other devices, purchased the intellectual property in 2015 from the previous 510(k) holder, but FDA has been unable to verify this information. The devices may have unknown performance characteristics because the firm is unable to provide any documentation that the devices were manufactured in conformance with the Quality System regulation, including documentation (e.g., DHF) that the distributed devices had not been modified since original clearance in a way that could impact their safety and effectiveness, documentation of controlled storage temperature/humidity, and post-market surveillance documentation, such as complaints and adverse events.

FDAMay 22, 2023CA, FL, IL +5 more• Universal Meditech Inc.

DeTec hCG Pregnancy Urine Test Cassette Format, REG Cat: ... (Universal Meditech Inc.) – universal meditech inc (2023)

Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is also recall their tests because they are going out of business and would not be able to continue fulfilling any post-market responsibilities of these distributed products. UMI claims to hold 510(k)s for the other devices, purchased the intellectual property in 2015 from the previous 510(k) holder, but FDA has been unable to verify this information. The devices may have unknown performance characteristics because the firm is unable to provide any documentation that the devices were manufactured in conformance with the Quality System regulation, including documentation (e.g., DHF) that the distributed devices had not been modified since original clearance in a way that could impact their safety and effectiveness, documentation of controlled storage temperature/humidity, and post-market surveillance documentation, such as complaints and adverse events.

FDAMay 22, 2023CA, FL, IL +5 more• Universal Meditech Inc.

DiagnosUS hCG Pregnancy Serum/Urine Test Cassette Format ... (Universal Meditech Inc.) – universal meditech inc (2023)

Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is also recall their tests because they are going out of business and would not be able to continue fulfilling any post-market responsibilities of these distributed products. UMI claims to hold 510(k)s for the other devices, purchased the intellectual property in 2015 from the previous 510(k) holder, but FDA has been unable to verify this information. The devices may have unknown performance characteristics because the firm is unable to provide any documentation that the devices were manufactured in conformance with the Quality System regulation, including documentation (e.g., DHF) that the distributed devices had not been modified since original clearance in a way that could impact their safety and effectiveness, documentation of controlled storage temperature/humidity, and post-market surveillance documentation, such as complaints and adverse events.

FDAMay 22, 2023CA, FL, IL +5 more• Universal Meditech Inc.

PrestiBio Pregnancy Strips REF 100-4 25 HCG Test Strips (Universal Meditech Inc.) – universal meditech inc (2023)

Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is also recall their tests because they are going out of business and would not be able to continue fulfilling any post-market responsibilities of these distributed products. UMI claims to hold 510(k)s for the other devices, purchased the intellectual property in 2015 from the previous 510(k) holder, but FDA has been unable to verify this information. The devices may have unknown performance characteristics because the firm is unable to provide any documentation that the devices were manufactured in conformance with the Quality System regulation, including documentation (e.g., DHF) that the distributed devices had not been modified since original clearance in a way that could impact their safety and effectiveness, documentation of controlled storage temperature/humidity, and post-market surveillance documentation, such as complaints and adverse events.

FDAMay 22, 2023CA, FL, IL +5 more• Universal Meditech Inc.

Hemospray Endoscopic Hemostat: Reference Part Numbers: ... (Wilson-Cook Medical Inc.) – there are potential risks of the hemo... (2023)

There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, which can result in adhesion of the endoscope to tissue and consequent difficulty or inability to maneuver/remove the endoscope.

FDAMay 22, 2023Nationwide• Wilson-Cook Medical Inc.

PrestiBio URINALASYS TEST STRIP 10 PARAMETERS REF 900-10 (Universal Meditech Inc.) – universal meditech inc (2023)

Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is also recall their tests because they are going out of business and would not be able to continue fulfilling any post-market responsibilities of these distributed products. UMI claims to hold 510(k)s for the other devices, purchased the intellectual property in 2015 from the previous 510(k) holder, but FDA has been unable to verify this information. The devices may have unknown performance characteristics because the firm is unable to provide any documentation that the devices were manufactured in conformance with the Quality System regulation, including documentation (e.g., DHF) that the distributed devices had not been modified since original clearance in a way that could impact their safety and effectiveness, documentation of controlled storage temperature/humidity, and post-market surveillance documentation, such as complaints and adverse events.

FDAMay 22, 2023CA, FL, IL +5 more• Universal Meditech Inc.

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