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Showing 8161–8180 of 11714 results

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PPM Lombard R2A Medium (Biomerieux) – Temperature Deviation (2022)

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

FDANov 9, 2022Nationwide• Biomerieux Inc

9 Gauge Disposable Trocars (ENDO Pharmaceuticals) – No Expiration Dates (2022)

No expiration dates printed on the packaging

FDANov 8, 2022Nationwide• ENDO Pharmaceuticals Solutions, Inc.

InPen Diabetes Management App (Companion Medical) – App Crash Risk (2022)

Diabetes management app may crash immediately upon opening, while using the app and/or while app is running in the background, which may lead to inability to use the app. An error message may be displayed indicating the app has stopped or isn't responding. After the crash, a present dose reminder is not displayed, which may lead to delayed insulin therapy and potentially resulting in hyperglycemia.

High

FDANov 8, 2022Nationwide• Companion Medical, Inc.

FoundationOne Liquid CDx (Foundation Medicine) – Missing Claims Page (2022)

Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of the issue occurrence.

FDANov 8, 2022Nationwide• Foundation Medicine, Inc.

FoundationOne CDx (Foundation Medicine) – Missing Claims Page (2022)

Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of the issue occurrence.

FDANov 8, 2022Nationwide• Foundation Medicine, Inc.

BIOLOX Delta Mod Head (Corin) – Incorrect Size Labeling (2022)

The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa.

FDANov 8, 2022Nationwide• Corin Ltd Unit 1-57-8 Corinium Centre Cirencester United Kingdom

Angiographic Catheter Extensions (Cordis) – Potential Separation (2022)

There is a potential for separation at the male connector.

FDANov 7, 2022Nationwide• Cordis US Corp

Tobra Full Dose Antibiotic (Howmedica) – Missing Translation (2022)

Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish language. Although the Turkish translation is missing, all content within the IFUs is accurate.

FDANov 7, 2022IN• Howmedica Osteonics Corp.

Flow-c Anesthesia System (Getinge) – Battery Failure Risk (2022)

The power backup battery, under certain conditions, may exhibit reduced battery run-time while in use, and there is a potential that the battery may fail to provide the expected run time in the event of a mains power failure. This could require the clinician to use manual emergency ventilation of another ventilator is not available and the backup battery is exhausted.

FDANov 7, 2022Nationwide• Getinge Usa Sales Inc

CBC-3D Hematology Control (R&D Systems) – Contamination Risk (2022)

For one lot of CBC-3D Hematology Control, the Normal Level may exhibit hemolysis or deterioration due to microbial contamination.

FDANov 7, 2022Nationwide• R & D Systems, Inc.

Full Dose Simplex P Bone Cement (Howmedica) – Missing Translation (2022)

Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish language. Although the Turkish translation is missing, all content within the IFUs is accurate.

FDANov 7, 2022IN• Howmedica Osteonics Corp.

Hand Sanitizer (Adam's Polishes) – Chemical Contamination (2022)

Chemical Contamination: FDA analysis found 1 lot of Adam's Polishes ALCOHOL BASED HAND SANITIZER isopropyl alcohol 75% v/v to contain methanol.

FDANov 5, 2022Nationwide• Adam's Polishes LLC

Hand Sanitizer (Adam's Polishes) – Manufacturing Deviation (2022)

CGMP Deviations: Other lots of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.

Class IIModerate

FDANov 5, 2022Nationwide• Adam's Polishes LLC

Port a Cath Kit (Medical Action) – Unspecified Issue (2022)

XXX

FDANov 4, 2022Nationwide• Medical Action Industries, Inc.

HF Resection Electrodes (Olympus) – Incompatible Cable (2022)

An incompatible HF cable may be packaged with the HF Resection Electrodes. This cable cannot be connected to the electrosurgical generator and may lead to delay or cancellation of the surgical procedure.

FDANov 4, 2022Nationwide• Olympus Corporation of the Americas

IMMULITE 2000 Allergy IgE Kit (Siemens) – False Reactivity Risk (2022)

Potential for falsely elevated specific IgE mold allergen reactivity with quality control material and patient samples, may result in false reactive result

FDANov 4, 2022Nationwide• Siemens Healthcare Diagnostics, Inc.

DeRoyal Basic Neuro Pack (DeRoyal) – Steri Drapes Concern (2022)

DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

FDANov 3, 2022AL, AZ, CT +20 more• DeRoyal Industries Inc

DeRoyal Laminectomy Pack (DeRoyal) – Unspecified Issue (2022)

XXX

FDANov 3, 2022AL, AZ, CT +20 more• DeRoyal Industries Inc

DeRoyal Cardiac Linen Pack (DeRoyal) – Unspecified Issue (2022)

XXX

FDANov 3, 2022AL, AZ, CT +20 more• DeRoyal Industries Inc

DeRoyal Tracecart Posterior Lumbar Fusion (DeRoyal) – Unspecified Issue (2022)

XXX

FDANov 3, 2022AL, AZ, CT +20 more• DeRoyal Industries Inc

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