Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX070301CD; Edwards Lif
FDA device recall Z-1281-2008 · posted 2008-07-02 · Terminated
Recall details
- Recalling firm
- Edwards Lifesciences, Llc
- Reason for recall
- Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised.
- Action taken
- Consignees were notified by an Urgent Product Recall letter sent on 12/5/07. The letter instructed users to return any affected product to the recalling firm for replacement products. The letter also advised users that the likelihood of patient complications is extremely low for products that have already been implanted in patients. Users were requested to return a confirmation form after checking the inventory for any affected products. For additional information, contact 1-949-250-3779.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 2 UNITS
- Distribution
- Nationwide Distribution
- Date initiated
- 2007-12-05
- Date posted
- 2008-07-02
- Date terminated
- 2012-01-11
- Location
- Irvine, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIFESTENT FLEXSTART BILIARY STENT SYSTEM (K053404) | Edwards Lifesciences, LLC | 2005-12-21 |