Recall Z-1677-2022 ยท DYB Introducer, Catheter
Biosense Webster, Inc.
CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into the heart.
| Date | Jun 29, 2022 |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Material/Component Contamination |
| Action | On 6/29/22, re call notices started being emailed and mailed to customers who were asked to do the following: 1) The notice should be forwarded to anyone in the facility that needs to be aware. 2) Identify affected devices, unbox devices, and destroy the devices. 3) Complete and return the Business Reply Form and send back the label on empty boxes to receive credit. 4) If any of the affected products have been forwarded to another facility, contact that facility, and provide a copy of this letter to the relevant personnel. 5) Maintain a copy of this communication where the product identified i |
| Quantity | 98 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170997 | CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath Biosense Webster, Inc., Jul 25, 2017 |