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IMPIX 3D (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.

Moderate

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

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.

High

FDAJul 11, 2023Nationwide• Boston Scientific Corporation

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IMPIX 3D (Medicrea) – Packaging Pinhole Issue (2023)

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

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

Atellica CH Total Bilirubin_2 -In vitro diagnostic use in... (Siemens Healthcare Diagnostics, Inc.) – potential for reagent carryover on th... (2023)

Atellica CH LDL Cholesterol- In vitro diagnostic use in t... (Siemens Healthcare Diagnostics, Inc.) – potential for reagent carryover on th... (2023)

Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnost... (Siemens Healthcare Diagnostics, Inc.) – potential for reagent carryover on th... (2023)

Atellica CH HDL Cholesterol- In vitro diagnostic use in ... (Siemens Healthcare Diagnostics, Inc.) – potential for reagent carryover on th... (2023)

SurgiCount+ Software Application-indicated as an adjuncti... (Stryker Corporation) – potential for current software to mis... (2023)

50-GEL20; Ultrasound gel (Advance Medical Designs, Inc.) – mislabeling (2023)

Five S 5 3x65, REF: 0915612-06, sterile for single use, S... (Karl Storz Endoscopy) – flexible intubation endoscopes steri... (2023)

LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP Sys... (Alphatec Spine, Inc. 1950 Camino Vida Roble) – awl instrument adjustable drill butto... (2023)

Procedural kits containing ultrasonic transmission gel, I... (Advance Medical Designs, Inc.) – mislabeling (2023)

ASG-001; Ultrasound gel (Advance Medical Designs, Inc.) – mislabeling (2023)

TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00,... (Johnson & Johnson Surgical Vision, Inc.) – their is a potential that intraocular... (2023)

APK2 Pressure-Sensing Wheelchair Cushions (Aquila Corporation) – defective battery pack in wheelchair ... (2023)

SofTech Pressure-Sensing Wheelchair Cushions (Aquila Corporation) – defective battery pack in wheelchair ... (2023)

TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only (Johnson & Johnson Surgical Vision, Inc.) – their is a potential that intraocular... (2023)

Access Thyroglobulin Calibrators (Beckman Coulter, Inc.) – it has been determined through an int... (2023)

Medtronic InterStim Ground Pad REF 041826 (Medtronic Neuromodulation) – lot of interstim self-adhesive ground... (2023)

Total Hip Kit, REF DYNJ903275S; surgical convenience kit (MEDLINE INDUSTRIES, LP Northfield) – the prep solution included in the tot... (2023)