So far, the year 2014 has witnessed 14 medical device recalls.
The following are the 14 issued recalls reported by the U.S. Food and Drug Administration, beginning with the most recent.
1. McKesson Technologies recalled its McKesson Anesthesia Care, a computer-based clinical decision support system that communicates adverse drug event risks at pre-anesthesia evaluation and at the point-of-care. In one instance, the system presented data from a case not matched to the actual patient.
2. Merit Medical Systems recalled its custom procedural trays or kits that contained Hospira's 1% Lidoccaine HCl injection that were recalled due to visible particulate found in the injection.
3. Greatbatch Medical recalled its Standard Offset Cup Impactor citing inadequate sterilization.
4. Philips Respironics recalled its Trilogy Ventilator, saying a potential defect on the power management board could inhibit the ventilator from administering mechanical breaths.
5. GE Healthcare recalled five of its infant resuscitation systems due to improper assembly that could cause inaccurate oxygen regulation.
6. Medline Industries recalled its ACME Monaco Guidewire because the coating of the wire could potentially flake off.
7. Teleflex Medical recalled its ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port. The tracheal tube has the potential to kink, potentially cutting off airflow to the patient.
8. Codman Neuro recalled its TRUFILL n-BCA Liquid Embolic System due to an error in the instructions for use.
9. Tandem Diabetes Care recalled its insulin cartridges due to the potential for the cartridges to leak, resulting in either too much or too little insulin for the patient.
10. Covidien recalled its Puritan Bennett 840 Series Ventilator due to a software problem causing the ventilator to stop functioning.
11. Abbott Diabetes Care recalled its FreeStyle and FreeStyle Lite Blood Glucose Test Strips because the strips may provide erroneously low blood glucose results.
12. GE Healthcare recalled its Multi Absorber Original, Disposable that attaches to its advanced breathing system. The absorber may have thin walls, leading to the potential for a leak of anesthetic gases, ventilations and oxygenation.
13. Nephros recalled its In-Line Dual Stage Ultra Filter because marketing materials promoted the filter as a medical device when it is not.
14. Nephros also recalled its SafeSpout and SafeShower water filtration products saying if the filter breaks, patients could be exposed to harmful viruses and bacteria.
More Articles on Medical Devices:
FDA Proposes Medical Device Reclassification Rule
Medical Device Recalls Increased 97% Over Past 10 Years
How Medical Device Interoperability Could Save $35B Annually