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Stryker Cement Delivery Needle (Stryker) – Expired Product (2024)

Expired Products distributed to customers

FDAJun 3, 2024Nationwide• Stryker Corporation

Fresenius Blood Pump Rotor (Fresenius) – Dislodgement Risk (2024)

An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.

Moderate

FDAJun 3, 2024Nationwide• Fresenius Medical Care Holdings, Inc.

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Stryker Cement Delivery Needle (Stryker) – Expired Product (2024)

Fresenius Blood Pump Rotor (Fresenius) – Dislodgement Risk (2024)

Fresenius Blood Pump Rotor (Fresenius) – Dislodgement Risk (2024)

Nalu Neurostimulation Kit (Nalu Medical) – Signal Efficiency Problem (2024)

Stryker Single Use Device (Stryker) – Expired Product (2024)

Transfer Device (Microtek Medical) – Packaging Integrity Issue (2024)

Fresenius Blood Pump Rotor (Fresenius) – Dislodgement Risk (2024)

Fresenius Blood Pump Rotor (Fresenius) – Dislodgement Risk (2024)

Fresenius Blood Pump Rotor (Fresenius) – Dislodgement Risk (2024)

Fresenius Blood Pump Rotor (Fresenius) – Dislodgement Risk (2024)

Nanoplasty Bunion Correction System (Treace Medical) – Screw Interference (2024)

paraPAC 300 Ventilator (Smiths Medical) – Connector Detachment Risk (2024)

paraPAC Plus 310 Ventilator (Smiths Medical) – Connector Detachment Risk (2024)

Pneupac paraPAC Plus 300 Ventilator (Smiths Medical) – Tidal Volume Knob Risk (2024)

AXIOM Vertix MD (Siemens) – Fire Hazard (2024)

ZOLL Powerheart G5 AED (Zoll) – Protective Film Issue (2024)

AXIOM MULTIX MT X-ray Table (Siemens) – Fire Hazard (2024)

ABL800 FLEX Analyzer (Radiometer) – Calibration Solution Issue (2024)

MIC-KEY Feeding Tube Kit (Avanos) – Incomplete Risk Information (2024)

Zimmer Tourniquet Cuff (Stryker) – Mislabeling Issue (2024)