MULTI-LINK Pixel Coronary Stent System Size: 2.0 x 13 mm OTW Part Number: 1007830-13
FDA device recall Z-0862-03 · posted 2003-05-22 · Terminated
Recall details
- Recalling firm
- Guidant Corporation ACS
- Reason for recall
- Sterility compromised.
- Action taken
- The firm initially is notifying by letter dated May 6, 2003 and will plan visit follow-ups to collect quarantined product.
- Root cause
- Other
- Status
- Terminated
- Product code
- MAF
- Quantity affected
- 40
- Distribution
- NATIONWIDE
- Date initiated
- 2003-05-07
- Date posted
- 2003-05-22
- Date terminated
- 2004-12-01
- Location
- Temecula, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.