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Laryngeal Mask Airway Pack (Medline) – Labeling Problem (2023)

The case and each (i.e. packet) labels for the DYND3000xxP series do not include an expiration date, however, the lubricating jelly (MDS032280) included in the DYNDP3000xxP series is labeled with an expiration date.

Moderate

FDAMar 28, 2023Nationwide• MEDLINE INDUSTRIES, LP Northfield

YelloPort Elite Trocar (Surgical Innovations) – Sterility Concern (2023)

Optical Trocars sterility assurance can not be guaranteed

Moderate

FDAMar 28, 2023MA• Surgical Innovations Ltd 6 Clayton Wood Bank Lds Leeds United Kingdom

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Laryngeal Mask Airway Pack (Medline) – Labeling Problem (2023)

YelloPort Elite Trocar (Surgical Innovations) – Sterility Concern (2023)

Centricity PACS-IW (GE Healthcare) – Patient Info Risk (2023)

Distal Phasitron (Percussionaire) – Breathing Circuit Issue (2023)

Centricity Universal Viewer (GE Healthcare) – Patient Data Issue (2023)

GEM NEUROTUBE (Baxter) – brittle mesh tube (2023)

Omnicell IVX Station (OmniCell) – dose accuracy risk (2023)

TDHisto/Cyto Software (Technidata) – incorrect label info (2023)

JOURNEY II UNI Tibia Insert (Smith & Nephew) – mispack error (2023)

Flexible Grasping Forceps (Richard Wolf) – potential jaw malfunction (2023)

Flexible Grasping Forceps (Richard Wolf) – potential jaw malfunction (2023)

Shiley Tracheostomy Tube (Covidien) – connector diameter issue (2023)

ANGIOGUARD Guidewire System (Cordis) – potential separation risk (2023)

Flexible Biopsy Forceps (Richard Wolf) – potential jaw malfunction (2023)

Walgreens Bandages (ASO) – undeclared chemical (2023)

Rosuvastatin Tablets 10mg (Preferred Pharmaceuticals) – Manufacturing Deviation (2023)

Atorvastatin Calcium Tablets 10mg (Preferred Pharmaceuticals) – Manufacturing Deviation (2023)

Simvastatin Tablets 80mg (Preferred Pharmaceuticals) – Manufacturing Deviation (2023)

Rosuvastatin Tablets 5mg (Preferred Pharmaceuticals) – Manufacturing Deviation (2023)

Glimepiride Tablets 4mg (Preferred Pharmaceuticals) – Manufacturing Deviation (2023)