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Repeater Bone Tamp (Integrity Implants) – Component Incompatibility (2024)

Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C).

FDADec 20, 2024Nationwide• Integrity Implants Inc.

Levothyroxine Tablets 75mcg (Lupin) – impurity specification (2024)

Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.

Class IIModerate

FDADec 20, 2024IN, OH• Lupin Pharmaceuticals Inc.

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Repeater Bone Tamp (Integrity Implants) – Component Incompatibility (2024)

Levothyroxine Tablets 75mcg (Lupin) – impurity specification (2024)

Clearlink System Solution Set (Baxter) – Inverted Side Clamps (2024)

Continu-Flo Solution Set (Baxter) – Inverted Side Clamps (2024)

HOT AXIOS Stent Delivery System (Boston Scientific) – Outer Sheath Issue (2024)

Adrenalin Nasal Solution (ENDO) – misleading label (2024)

Rajbhog Jelebi Yellow (Rajbhog Distributors) – Undeclared Milk (2024)

Buttered Vegetables (Lidl) – Undeclared Milk (2024)

Rajbhog Jelebi Orange (Rajbhog Distributors) – Undeclared Milk (2024)

8MM Long Bipolar Grasper (Intuitive Surgical) – Grip Cable Failure (2024)

8MM Round Tip Scissors (Intuitive Surgical) – Grip Cable Failure (2024)

8MM Long Tip Forceps (Intuitive Surgical) – Grip Cable Failure (2024)

8MM Cadiere Forceps (Intuitive Surgical) – Grip Cable Failure (2024)

KARL STORZ Uretero-Renoscope (Karl Storz) – Reprocessing Modality Issue (2024)

8MM Small Graptor (Intuitive Surgical) – Pitch Cable Failure (2024)

8MM Tenaculum Forceps (Intuitive Surgical) – Grip Cable Failure (2024)

8MM Cobra Grasper (Intuitive Surgical) – Grip Cable Failure (2024)

8MM ProGrasp Forceps (Intuitive Surgical) – Grip Cable Failure (2024)

Karl Storz Endoskope Biopsy Forceps (Karl Storz) – Cleaning Validation Failure (2024)

KARL STORZ Uretero-Renoscope (Karl Storz) – Reprocessing Modality Issue (2024)