CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Catheter Sheath Introducer (CSI) and a vessel dilator. A Catheter Sheath Introducer facilitates percutaneous entry of an intravascular device. A vessel dilator facilitates the percutaneous entry of the CSI by forming an atrauma
Check against the official notice below — it lists the full affected range.
Cordis Corporation has recalled 1,985 units of the CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM due to an incorrect cannula on the sheath introducer that is smaller than intended. The affected product is Catalog No. 504656X with Lot No. 17305580 and an expiration date of July 31, 2018. The recalled units were distributed nationwide across the United States.
The source does not specify a remedy or actions for affected consumers to take.
Written by software from the official notice below. Not reviewed by a lawyer.
Incorrect cannula of the sheath introducer (smaller than intended).
Reason for recall: Incorrect cannula of the sheath introducer (smaller than intended). Distribution: US Nationwide Distribution including states of:AL, AZ, CA, CO, CT, FL, GA, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NJ,NY, OH, OR, PA, RI, TN, TX, VA, WA, WV, and Hawaii. Quantity: 1,985 units Lot/code info: Catalog No. 504656X (GTIN: 20705032010389) Lot No. 17305580, Expiration date: 2018-07-31.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.