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Showing 5741–5760 of 68218 results

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Organic Aussie Bites (Universal Bakery) – Undeclared gluten (2024)

Undeclared Gluten

Potential undeclared gluten product is labeled as gluten free but consumer advocacy group testing revealed results above 20ppm for gluten.

Class IIModerate

FDAJun 18, 2024AZ, CA, CO +10 more• Best Express Foods, Inc.

Dodex Injectable (Accord Healthcare) – Subpotent Drug (2024)

Subpotent drug: out of specification results

FDAJun 18, 2024Nationwide• Accord Healthcare, Inc.

Venlafaxine Hydrochloride (Major Pharmaceuticals) – Dissolution Failure (2024)

Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.

Class IIModerate

FDAJun 18, 2024Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Delflex Peritoneal Dialysis Solution (Fresenius) – Tube Weld Failure (2024)

This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.

Class IIModerate

FDAJun 18, 2024Nationwide• Fresenius Medical Care Holdings, Inc.

Pediatric Craniotomy Kit (Medline) – Sterility Labeling Issue (2024)

A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience kits and distributed. In the event that the user assumes sterility during its use, there is an increased risk of patient infection.

FDAJun 18, 2024CA, IL, TX• MEDLINE INDUSTRIES, LP Northfield

Paleo Bars (SureLife Foods) – Undeclared gluten (2024)

Undeclared Gluten

Potential undeclared gluten product is labeled as gluten free but consumer advocacy group testing revealed results above 20ppm for gluten.

Class IIModerate

FDAJun 18, 2024CA, OR• Best Express Foods, Inc.

Infusomat Universal Pump Set (B. Braun) - Backflow Risk (2024)

Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

FDAJun 17, 2024Nationwide• B. Braun Medical, Inc.

Infusomat Space Pump IV Set (B. Braun) - Backflow Risk (2024)

Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

FDAJun 17, 2024Nationwide• B. Braun Medical, Inc.

Infusomat Space Pump IV Set (B. Braun) - Backflow Risk (2024)

Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

FDAJun 17, 2024Nationwide• B. Braun Medical, Inc.

Handset with Communicator (Medtronic) - Pairing Issue (2024)

A subset of the handsets within the kit may not be able to complete the pairing process with the communicator upon initial setup.

FDAJun 17, 2024Nationwide• Medtronic Neuromodulation

Outlook IV Set (B. Braun) - Backflow Risk (2024)

Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

FDAJun 17, 2024Nationwide• B. Braun Medical, Inc.

Mega Soft Patient Electrode (Megadyne) - Age Limitation (2024)

To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads.

FDAJun 17, 2024Nationwide• Megadyne Medical Products, Inc.

Infusomat Universal 60 Drop Pump Set (B. Braun) - Backflow Risk (2024)

Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

FDAJun 17, 2024Nationwide• B. Braun Medical, Inc.

Outlook IV Set (B. Braun) - Backflow Risk (2024)

Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

FDAJun 17, 2024Nationwide• B. Braun Medical, Inc.

Afinion 2 Analyzer (Abbott) - Complexity Configuration (2024)

Five Afinion 2 (AF2) Analyzer were incorrectly market configured as Moderate Complexity and distributed to customers. Use of moderately complex assays by waived laboratories could result in erroneous results.

FDAJun 17, 2024Nationwide• Abbott Diagnostics Technologies AS Kjelsasveien

Infusomat Metriset Pump Set (B. Braun) - Backflow Risk (2024)

Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

FDAJun 17, 2024Nationwide• B. Braun Medical, Inc.

Infusomat Universal Pump Set (B. Braun) - Backflow Risk (2024)

Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

FDAJun 17, 2024Nationwide• B. Braun Medical, Inc.

Infusomat Metriset Pump Set (B. Braun) - Backflow Risk (2024)

Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

FDAJun 17, 2024Nationwide• B. Braun Medical, Inc.

Outlook Pump Set (B. Braun) - Backflow Risk (2024)

Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

FDAJun 17, 2024Nationwide• B. Braun Medical, Inc.

Outlook Pump Set (B. Braun) - Backflow Risk (2024)

Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

FDAJun 17, 2024Nationwide• B. Braun Medical, Inc.

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