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PVP Solution (Medline) – non-sterile contents (2023)

The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.

High

FDANov 3, 2023Nationwide• MEDLINE INDUSTRIES, LP Northfield

Cobas Interface Module (Inpeco) – delayed tube processing (2023)

Firmware of the Interface Module with Roche Cobas 8000 and Cobas PRO (CO8 IM) may lead to a delayed sample tube processing.

Low

FDANov 3, 2023Nationwide• Inpeco S.A. Via San Gottardo 10 Lugano Switzerland

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PVP Solution (Medline) – non-sterile contents (2023)

Cobas Interface Module (Inpeco) – delayed tube processing (2023)

Sterile Prep Stick (Medline) – non-sterile contents (2023)

Quantum Biliary Balloon Dilator (Wilson-Cook) – device nonconformity (2023)

Multi-Mode Stimulator (Liberty Medical) – incomplete warnings (2023)

Sterile Povidone (Medline) – non-sterile contents (2023)

Sterile PVP (Medline) – non-sterile contents (2023)

LINQ II Cardiac Monitor (Medtronic) – signal interference (2023)

Azurion Systems (Philips) – ceiling mount collision risk (2023)

Sterile PVP Solution Kit (Medline) – non-sterile contents (2023)

Biolox Ceramic Option Head (Biomet) – incorrect adapter (2023)

Sperm Separation Media (Fujifilm) – component mismatch (2023)

Blood Culture Kit (Medline) – expired component (2023)

Central Line Blood Culture Kit (Medline) – expired component (2023)

Peripheral Blood Culture Kit (Medline) – expired component (2023)

24 Blood Culture Kit (Medline) – expired component (2023)

Adult Blood Culture Kit (Medline) – expired component (2023)

Stratus Imaging PACS (Change Healthcare) – message association error (2023)

Guardian 2 System (Turncare) – battery alert issue (2023)

LITe Decompression Snake Arm (Stryker) – incorrect clamp (2023)