Cordis, AVANTI+ Introducer, STERILE EO, For one use only. Catalog 402656X Lot # 15076369. Catalog 504606X Lot # 15075717. Catalog 504656X Lot # 15076362, 15076363, 15076364.
This recall has been terminated (originally issued April 20, 2010).
- Company
- Cordis Corporation
- Recall Initiated
- January 28, 2010
- Posted
- April 20, 2010
- Terminated
- July 27, 2012
- Recall Number
- Z-1421-2010
- Quantity
- 1850 units
- Firm Location
- Miami Lakes, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Sterility compromised: Cordis found a pin hole in one of the packaging tray cavities.On January 28, 2010 Cordis Corporation initiated a recall on their AVANTI + Introducer. During routine inspection, a visual irregularity was detected in packing trays.
Distribution
Nationwide.
Lot / Code Info
Catalog 402656X Lot # 15076369. Catalog 504606X Lot # 15075717. Catalog 504656X Lot # 15076362, 15076363, and 15076364.
Root Cause
Package design/selection
Action Taken
Cordis initiated the recall January 28, 2010. (The packets were sent overnight on January 28, 2010, with first receipt by customers January 29, 2010.) Immediate corrective action was taken through an inspection and removal of all affected products.