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Crani Procedural Tray (Medline) – Non-Sterile Blade Risk (2022)

Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.

Moderate

FDANov 17, 2022Nationwide• MEDLINE INDUSTRIES, LP Northfield

Local Pack (Medline) – Blade Puncture Risk (2022)

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Moderate

FDANov 17, 2022Nationwide• MEDLINE INDUSTRIES, LP Northfield

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Crani Procedural Tray (Medline) – Non-Sterile Blade Risk (2022)

Local Pack (Medline) – Blade Puncture Risk (2022)

Universal Core Dr Runnels Pack (Medline) – Blade Puncture Risk (2022)

OttLite UVC Disinfecting Wand (Ottlite) – UV Radiation Excess (2022)

Ancillary Pack (Medline) – Blade Puncture Risk (2022)

Femoral Artery Pack (Medline) – Blade Puncture Risk (2022)

Trach Pack (Medline) – Blade Puncture Risk (2022)

Pain Service Pack (Medline) – Blade Puncture Risk (2022)

Sterile Procedural Cardiac Cath Tray (Medline) – Blade Puncture Risk (2022)

VITROS PTH Reagent Pack (Ortho-Clinical) – Result Bias (2022)

Programmable Diagnostic Computer (Siemens) – Software Update (2022)

B125M Patient Monitor (GE Medical) – CO2 Measurement Error (2022)

B105P Patient Monitor (GE Medical) – CO2 Measurement Error (2022)

B125P Patient Monitor (GE Medical) – CO2 Measurement Error (2022)

PDS II Suture (Ethicon) – Knot Tensile Weakness (2022)

B105M Patient Monitor (GE Medical) – CO2 Measurement Error (2022)

Daytrana (Noven) – Defective Adhesive System (2022)

AQUACEL Foam Ag Adhesive (ConvaTec) – Visual Contamination (2022)

iTotal Identity Impactor Handle (Conformis) – Screw Loosening (2022)

Omnipod 5 Insulin System (Unknown) – Charging Port Melting (2022)