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Spine Pack (Windstone) – Light Handle Detachment (2023)

Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient

Moderate

FDAApr 24, 2023MA• Windstone Medical Packaging, Inc.

SMMT ambIT Kit (Avanos) – Missing Filter (2023)

Some of the ambIT kits were potentially distributed without an air in-line filter.

Moderate

FDAApr 24, 2023Nationwide• Avanos Medical, Inc.

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Spine Pack (Windstone) – Light Handle Detachment (2023)

SMMT ambIT Kit (Avanos) – Missing Filter (2023)

AVNS ambIT System (Avanos Medical) - Air Filter Issue (2023)

Aspira Pleural Drainage Catheter Tray (Merit Medical) - Valve Malfunction (2023)

Aspira Drainage Catheter Tray (Merit Medical) - Valve Malfunction (2023)

Aspira Valve Repair Kit (Merit Medical) - Valve Malfunction (2023)

Aspira Peritoneal Drainage Catheter Tray (Merit Medical) - Valve Malfunction (2023)

LNCS TC-I SpO2 Ear Sensor (Masimo) - Reading Accuracy Problem (2023)

Sterile Arthroscopy Pack (Medline) - Water Damage (2023)

RD Set TC-I SpO2 Ear Sensor (Masimo) - Reading Accuracy Problem (2023)

LNOP TC-I SpO2 Ear Sensor (Masimo) - Reading Accuracy Problem (2023)

Magic3 Go Urinary Catheters (C.R. Bard) - Label Separation Risk (2023)

HydroSil Go Urinary Catheters (C.R. Bard) - Label Separation Risk (2023)

Patient Information Center iX (Philips) - DHCP Lease Expiration (2023)

Single Use Distal Cover (Olympus) - Mucosal Injury Risk (2023)

VITROS HbA1c Reagent Kit (Ortho-Clinical) - Result Inaccuracy (2023)

Impella 5.5 Catheter (Abiomed) - Purge Leak Concern (2023)

Anesthesia Circuit Kit Coax 1 (Draeger) - Circuit Connection Risk (2023)

VentStar Breathing Bag (Draeger) - Circuit Connection Risk (2023)

ID Circuit Basic (Draeger) - Circuit Connection Risk (2023)