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Allen Standard Spine Positioners (Baxter) – Adhesive Holding Issue (2022)

the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.

Moderate

FDASep 20, 2022MI, TX, WA +1 more• Baxter Healthcare Corporation

Allen Life Assist Beach Chair (Baxter) – Adhesive Holding Problem (2022)

the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.

Moderate

FDASep 20, 2022MI, TX, WA +1 more• Baxter Healthcare Corporation

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Allen Standard Spine Positioners (Baxter) – Adhesive Holding Issue (2022)

Allen Life Assist Beach Chair (Baxter) – Adhesive Holding Problem (2022)

da Vinci X (Intuitive Surgical) – Inadvertent Energy Delivery (2022)

Teleflex RUSCH Pocket Pac (Teleflex) – Potential Non-Sterile (2022)

MiniMed Insulin Pump (Medtronic) – Cybersecurity Vulnerability (2022)

Beach Chair Clamp (Baxter) – Adhesive Holding Failure (2022)

Simple Clamp (Baxter) – Adhesive Holding Failure (2022)

Allen Advance Table (Baxter) – Adhesive Holding Failure (2022)

Vortex MP Port (Angiodynamics) – Missing Instructions (2022)

ARTIS pheno X-Ray System (Siemens) – Software Issue (2022)

STRATAFIX SPIRAL PGA-PCL (Ethicon) – Incorrect Needle Type (2022)

C-Flex Polar Head Positioner (Baxter) – Adhesive Holding Failure (2022)

Atellica CH Lithium Test (Siemens) – False Results Risk (2022)

iGO2 Oxygen Concentrator (DeVilbiss) – Unapproved Adhesive (2022)

Atellica CH Lithium Test (Siemens) – False Results Risk (2022)

Berkeley VC-10 System (Olympus) – IFU Update (2022)

Prep-Fill Connector (IMI) – Compromised Sterility (2022)

CARESITE Extension Set (B. Braun) – Joint Failure Risk (2022)

ULTRASITE Extension Set (B. Braun) – Joint Failure Risk (2022)

Extension Set (B. Braun) – Joint Failure Risk (2022)