Surgical Tubing Pack, Model: AMO Prestige Pack, Product Code OPO40
FDA device recall Z-0907-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Allergan Medical Optics Inc
- Reason for recall
- The lots are being recalled because the tray lid may not be adequately sealed under the red arrow in the upper right corner of the package tray. The blue wrapping within the tray may not be sterile and may pose a potential risk of infection to the patient if used in a sterile field.
- Action taken
- On March 31, 2004, a product notification letter was mailed to all customers via certified mail. The customers were instructed to stop using, quarantine and return all units. They were instructed to complete the Facsimile form provided and faxed it to the AMO Customer Service at 888-324-0021. They were also instructed to call AMO Customer Service at 800-366-6554 to make arrangement to return the product.
- Root cause
- Other
- Status
- Terminated
- Product code
- HQC
- Quantity affected
- 19, 087
- Distribution
- Distribution was to 67 domestic customers and internationally.
- Date initiated
- 2004-03-29
- Date posted
- 2004-07-20
- Date terminated
- 2004-11-04
- Location
- Santa Ana, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AMO ELITE (K924235) | Allergan Medical Optics | 1992-12-23 |