Cordis, AVANTI+ Introducer, STERILE EO, For one use only. Catalog 402656X Lot # 15076369. Catalog 504606X Lot # 15075717
FDA device recall Z-1421-2010 · posted 2010-04-20 · Terminated
Recall details
- Recalling firm
- Cordis Corporation
- 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.
- 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.
- Root cause
- Package design/selection
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 1850 units
- Distribution
- Nationwide.
- Date initiated
- 2010-01-28
- Date posted
- 2010-04-20
- Date terminated
- 2012-07-27
- Location
- Miami Lakes, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CORDIS AVANTI CATHETER SHEATH INTRODUCER (K945616) | Cordis Corp. | 1995-03-29 |