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Hand Sanitizer (Fisher) - CGMP Manufacturing Issue (2023)

CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary approval, into the market after March 31, 2022.

Class IIModerate

FDAJan 17, 2023Nationwide• Fisher Scientific Co., LLC

Siemens Biograph Horizon (Siemens) – Gantry Locking Issue (2023)

This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.

Moderate

FDAJan 16, 2023Nationwide• Siemens Medical Solutions USA, Inc.

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Hand Sanitizer (Fisher) - CGMP Manufacturing Issue (2023)

Siemens Biograph Horizon (Siemens) – Gantry Locking Issue (2023)

Irvine Scientific Embryo Oil (Fujifilm) – Oil Toxicity (2023)

Siemens Biograph mCT (Siemens) – Gantry Locking Issue (2023)

Hologic 3Dimensions (Hologic) – C-Arm Movement Risk (2023)

Siemens Biograph Vision (Siemens) – Gantry Locking Issue (2023)

Nasal Septal Button (Summit Medical) – Unsealed Pouches (2023)

Parietex Composite Mesh (Unknown) – Film Placement Risk (2023)

Techni-Care Chloroxylenold (Consolidated) - CGMP Violation (2023)

Humatrix Microclysmic Gel (Consolidated) - CGMP Violation (2023)

Atellica IM Folate 700 Test Kit (Siemens) – Calibration Bias (2023)

ADVIA Centaur Folate 100 Test Kit (Siemens) – Calibration Bias (2023)

ADVIA Centaur Folate 500 Test Kit (Siemens) – Calibration Bias (2023)

Atellica IM Folate 140 Test Kit (Siemens) – Calibration Bias (2023)

Respiratory Care Breathing Circuit (S & Mohr) – Expiration Label Error (2023)

Broviac Catheter Repair Kit (Bard) – Adhesive Hardening (2023)

Smart Correction Dual Joint Struts (Wishbone) – Adjustment Pin Issue (2023)

FluidShield Procedure Mask (Owens & Minor) – Incorrect Box Labeling (2023)

Digital VIPR Oxygen Gauge (Western/Scott Fetzer) – Pressure Malfunction (2023)

Vanguard Knee System (Biomet) – Incorrect Component Labeling (2022)