Vistabritetip IG Introducer, Introducer Guide. Labeled as sterile, sterilized with ethylene oxide gas. For single use on
FDA device recall Z-0588-05 · posted 2005-03-10 · Terminated
Recall details
- Recalling firm
- Cordis Corporation
- Reason for recall
- The product is labeled as Straight Catheter but the package contains Contralateral Guide shaped Catheters.
- Action taken
- A recall letter dated 04/30/2004 was sent to the consignees, instructing them to discontinue using the product and informed them that a Cordis representive would remove any unit in their possesion.
- Root cause
- Other
- Status
- Terminated
- Product code
- DQY
- Quantity affected
- 40
- Distribution
- Distributed in FL, OK, SC, and KS in the US. Internationaly to South Africa and the Netherlands.
- Date initiated
- 2004-05-05
- Date posted
- 2005-03-10
- Date terminated
- 2008-11-21
- Location
- Miami Lakes, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CORDIS INTRODUCER GUIDE (K001136) | Cordis Corp. | 2000-04-28 |