SILVER SPRING, MD — The US Food and Drug Administration (FDA) has announced a Class I recall of reprocessed Agilis steerable introducer sheaths made by Sterilmed because of the potential for device failure[1].
The Agilis steerable introducer sheath is used for cardiac catheterization procedures. According to the FDA, the sheath’s hemostatic valve, which prevents blood from flowing back through the valve, may fail because of an improper seal of the sheath hub. Improper seals can allow blood to leak through the hub, cause the cap to fall off during the procedure, or can create a difference in pressure leading to air embolism.
“The use of affected products may cause serious health consequences for patients, including death,” the FDA warns in their statement posted January 2.
All Sterilmed reprocessed Agilis steerable introducer sheaths manufactured and distributed between January 1 and May 5, 2017 have been recalled. The model numbers are STJ408309, STJ408310, and STJG408324. A total of 112 devices are affected. The recall began in June 2017, the announcement notes.
Sterilmed has asked healthcare facilities and providers to examine inventory to determine if they have the recalled product; do not use any of the affected products, and return any unused product to the company; share this information with the appropriate facility staff; and continue to monitor patients treated with the Sterilmed reprocessed Agilis steerable introducer sheath as normal.
For more information, contact Sterilmed at 888-541-0078 or sterilmedcs@its.jnj.com
Healthcare professionals are encouraged to report adverse events or side effects related to this recall to MedWatch, the FDA’s safety information and adverse event reporting program.
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