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Intra-Aortic Balloon Catheter (Datascope) – contamination (2020)

Potential Endotoxin Contamination

Moderate

FDAJul 27, 2020Nationwide• Datascope Corporation

Intra-Aortic Balloon Catheter (Datascope) – contamination (2020)

Potential Endotoxin Contamination

Moderate

FDAJul 27, 2020Nationwide• Datascope Corporation

Intubation Fiberscope (Karl Storz) – sterilization update (2020)

Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable flexible intubation endoscopes with total lumen lengths greater than 850mm. Incompletely sterilized endoscopes might introduce infectious agents into patient airways, resulting in infection.

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Intra-Aortic Balloon Catheter (Datascope) – contamination (2020)

Intra-Aortic Balloon Catheter (Datascope) – contamination (2020)

Intubation Fiberscope (Karl Storz) – sterilization update (2020)

Mercedes-Benz Sprinter (Mercedes-Benz) – chassis stability (2020)

Plastic Cannula (Greiner) – sample leakage (2020)

Peterbilt 520 (Peterbilt) – steering bolt issue (2020)

Great Dane Truck Body (Great Dane) – lighting problem (2020)

Precice Bone Transport System (NuVasive) – removal risk (2020)

Kiel Avance (Kiel) – seat belt retractor fault (2020)

Keystone Impact (Keystone) – wiring problem (2020)

Mercedes-Benz GLE 350 (Mercedes-Benz) – seat bolt missing (2020)

Wintergreen and Birch Oils (Bulk Apothecary) – safety compliance (2020)

Home Accents Holiday Trees (Willis Electric) – burn hazard (2020)

Ranger Off-Road Vehicles (Polaris) – crash risk (2020)

Wintergreen Essential Oil (BioMed Balance) – Child Safety (2020)

Kia Stinger (Kia) – steering system fault (2020)

Thor Motor Coach Tellaro (Thor) – seat belt length (2020)

CombiDiagnost R90 (Philips) – software value lock (2020)

SimmerLite Dutch Ovens (Greenpan) – Burn Injury Risk (2020)

Manhattan Ball (Manhattan Toy) – Choking Hazard (2020)