Medical equipment, implants, and diagnostic devices
bioMerieux
Software issue where results sent to the LIS via HL7 format for antibiotic screen tests and synergy tests do not include the user-corrected or AES-corrected interpretation. This can potentially lead to incorrect final screen/synergy test results at the LIS.
Olympus Corporation of the Americas
Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization
FDA review concluded that the test is insufficiently supported by clinical performance data, and results reported may not have been accurate (false positives or false negatives).
DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include: Infection, sepsis, osteomyelitis.
Olympus Corporation of the Americas
Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization
Medtronic Vascular
Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
Karl Storz Endoscopy
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Karl Storz Endoscopy
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Instrumentation Laboratory
Variable and out of specification QC results with HemosIL ReadiPlasTin. IL will remove all lots from the market and convert customers to an alternative prothrombin time (PT) reagent, specifically HemosIL RecombiPlasTin 2G.
Woodside Acquisitions
Firm distributed tests which have not been cleared or authorized for marketing or distribution in the United States.
American Contract Systems
Product was sterilized with a higher than specification EO concentration.
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Olympus Corporation of the Americas
Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
American Contract Systems
Product was sterilized with a higher than specification EO concentration.
Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.
Olympus Corporation of the Americas
Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization
SIMPLIVIA HEALTHCARE
Disconnection of the OnGuard2 Bag Adaptor SP from infusion bags which may result in spillage of hazardous medications.
When a Neonatal patient is admitted, the Non-Invasive Blood Pressure is not set to Neonatal mode on the Philips Xperflex Cardio FC2010 patient monitor. If the NIBP is not set to Neonatal, the cuff inflation pressure applied will be higher than 150 mmHg and the deflation pressure will be higher than 5 mmHg. An applied cuff inflation pressure higher than 150mmHg or a deflation pressure higher than 5 could lead to bruising, mmHg nerve damage or bone deformity for a neonate.
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.