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ATTUNE Measured Sizing Guide (DePuy Orthopaedics) – Incorrect Spring Material (2022)

Manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless steel spring. has the potential to oxidize and corrode in the ATTUNE Measured Sizing & Rotation Guide, resulting in surgical delay, debris in surgical field, Osteolysis, Poor Joint Mechanics, Soft Tissue Irritation, Pain

FDAJun 29, 2022Nationwide• DePuy Orthopaedics, Inc.

Atellica CH Iron_2 (Siemens Healthcare) – Falsely Elevated Results (2022)

Falsely Elevated Atellica CH Microalbumin_2 (ALB_2) Results due to Reagent Carryover from the Iron_2 Assay. This defect occurs only when a microalbumin test is run immediately after an iron test.

FDAJun 28, 2022Nationwide• Siemens Healthcare Diagnostics, Inc.

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ATTUNE Measured Sizing Guide (DePuy Orthopaedics) – Incorrect Spring Material (2022)

Atellica CH Iron_2 (Siemens Healthcare) – Falsely Elevated Results (2022)

HeartWare HVAD System Batteries (Heartware) – Battery Performance Issues (2022)

ChemoLock Bag Spike (ICU Medical) – Port Connection Variation (2022)

X-Stream Irrigation System (Davol) – Fire Safety Risk (2022)

Genesis II Non-Porous Tibial Baseplate (Smith & Nephew) – Mispackaged Product (2022)

HAMILTON-C6 Intensive Care Ventilator (Hamilton Medical) – Status Board Water Risk (2022)

Hill-Rom PRO+ MRS Versacare Mattress (Baxter) – Microclimate Management Failure (2022)

Hill-Rom Centrella Pro+ 40" Mattress (Baxter) – Microclimate Management Failure (2022)

UroLift System (Neotract) – Implant Delivery Potential Issue (2022)

Hill-Rom PRO+ 36" MRS X-Ray Mattress (Baxter) – Microclimate Management Failure (2022)

Medline Sprinter OTW (Medtronic) – Incorrect Balloon Diameter Print (2022)

Stryker 2.3mm Tapered Router (Stryker) – Potential Router Breakage (2022)

Cholestech LDX System (Alere) – Bilirubin Interference Update (2022)

Hill-Rom Centrella Pro+ Mattress (Baxter) – Microclimate Management Failure (2022)

SIGNA Premier MRI Scanner (GE Healthcare) – Acoustic Noise Concern (2022)

Hill-Rom PRO+ MRS Surface Mattress (Baxter) – Microclimate Management Failure (2022)

Clearblue Pregnancy Test (Family Dollar) – Improper Temperature Storage (2022)

Fixodent Denture Cream (Family Dollar) – Improper Temperature Storage (2022)

Opti Free Replenish Solution (Family Dollar) – Improper Temperature Storage (2022)