Surgical Tubing Pack, Model: AMO Prestige Pack, Product Code OPO40
FDA Recall Z-0907-04 · Posted 2004-07-20
Recalling FirmAllergan Medical Optics Inc
Recall StatusTerminated
Product CodeHQC
Date Initiated2004-03-29
Date Terminated2004-11-04
Product Quantity19, 087
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.
Firm Action
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
Distribution Pattern
Distribution was to 67 domestic customers and internationally.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.