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Showing 5041–5060 of 8389 results

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Allen Advance Chest Support (Baxter) – Potential Cracking (2023)

Potential for the device to crack where the Chest Base Prone support attaches to the carbon fiber operating room (OR) table rail.

FDAMay 18, 2023Nationwide• Baxter Healthcare Corporation

MEDLINE PVP Solution (Medline) – Mislabeling Issue (2023)

Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".

FDAMay 18, 2023Nationwide• MEDLINE INDUSTRIES, LP Northfield

Medline Probe Cover Kits (Medline) – Barrier Seam Inadequacy (2023)

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Moderate

FDAMay 18, 2023Nationwide• MEDLINE INDUSTRIES, LP Northfield

VITROS NT-proBNP II (Ortho-Clinical) – Stability Specification (2023)

May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU).

FDAMay 18, 2023Nationwide• Ortho-Clinical Diagnostics, Inc.

QUADROX-i Neonatal (Maquet) – Packaging Accessory Damage (2023)

1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.

FDAMay 18, 2023Nationwide• Maquet Medical Systems USA

QUADROX-iD (Maquet) – Packaging Accessory Damage (2023)

1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory s sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.

FDAMay 18, 2023Nationwide• Maquet Medical Systems USA

QUADROX-iR (Maquet) – Packaging Accessory Damage (2023)

1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.

FDAMay 18, 2023Nationwide• Maquet Medical Systems USA

QUADROX-i Adult (Maquet) – Packaging Pinhole Risk (2023)

Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.

FDAMay 18, 2023Nationwide• Maquet Medical Systems USA

QUADROX-iD Pediatric (Maquet) – Packaging Pinhole Risk (2023)

Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.

FDAMay 18, 2023Nationwide• Maquet Medical Systems USA

Venous Hardshell Cardiotomy Reservoir (Maquet) – Packaging Pinhole Risk (2023)

Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.

FDAMay 18, 2023Nationwide• Maquet Medical Systems USA

QUADROX-iR (Maquet) – Packaging Pinhole Risk (2023)

Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.

FDAMay 18, 2023Nationwide• Maquet Medical Systems USA

Medline Probe Cover Kits (Medline) – Barrier Seam Inadequacy (2023)

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

FDAMay 18, 2023Nationwide• MEDLINE INDUSTRIES, LP Northfield

QUADROX-i Neonatal (Maquet) – Packaging Pinhole Risk (2023)

Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.

FDAMay 18, 2023Nationwide• Maquet Medical Systems USA

QUADROX-i Small (Maquet) – Packaging Accessory Damage (2023)

1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.

FDAMay 18, 2023Nationwide• Maquet Medical Systems USA

QUADROX-i Adult (Maquet) – Packaging Accessory Damage (2023)

1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.

FDAMay 18, 2023Nationwide• Maquet Medical Systems USA

QUADROX-i Small Adult (Maquet) – Packaging Pinhole Risk (2023)

Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.

FDAMay 18, 2023Nationwide• Maquet Medical Systems USA

QUADROX-iD Adult (Maquet) – Packaging Accessory Damage (2023)

1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.

FDAMay 18, 2023Nationwide• Maquet Medical Systems USA

QUADROX-i Small Adult (Maquet) – Packaging Accessory Damage (2023)

1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.

FDAMay 18, 2023Nationwide• Maquet Medical Systems USA

Access Hybritech p2PSA Reagent (Beckman) – Blocking Reagent Concentration (2023)

Reagent lot numbers include an insufficient concentration of blocking reagent.

FDAMay 17, 2023CA, CO, CT +16 more• Beckman Coulter, Inc.

HeartWare VAD System (Heartware) – Monitor Logfile Issue (2023)

Medtronic has identified that the logfiles downloaded from the recently updated Model 1521 monitors (Serial Numbers: MON4xxxxxx for OUS and MON5xxxxxx for US), are unable to be processed by the Autologs web portal.

FDAMay 16, 2023Nationwide• Heartware, Inc.

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