CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into the heart.
Check against the official notice below — it lists the full affected range.
Biosense Webster, Inc. is recalling the CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath (REF: D138501), a device used to introduce cardiovascular catheters into the heart. The outside packaging of 98 units sustained water damage that may have compromised the sterile barrier protecting the device inside. A compromised sterile barrier could allow infection to occur. The affected devices have lot number 00002001 and were distributed nationwide across 18 states including California, Texas, Florida, New York, and others.
The recall notice does not specify what actions affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Outside packaging for a device indicated for introducing cardiovascular catheters into the heart, sustained water damage, which may have affected the sterile barrier of the product inside. Devices with a compromised sterile barrier could be a source for infection.
Reason for recall: Outside packaging for a device indicated for introducing cardiovascular catheters into the heart, sustained water damage, which may have affected the sterile barrier of the product inside. Devices with a compromised sterile barrier could be a source for infection. Distribution: US Nationwide distribution in the states of AL, GA, AZ, TX, MA, VA, NY, ME, FL, IA, NM, NH, TN, WI, OH, SC, CA, IN. Quantity: 98 Lot/code info: UDI-DI: 10846835016253, Lot Number: 00002001
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.